Moffitt's Dr. Jeffrey Weber, MD, PhD is a member of this conference's faculty, and will discuss Combination therapies in immunotherapy and targeted agents during Friday's session.
April 29, 2013
$PVCT: 2013 Annual Paris Melanoma Conference
Moffitt's Dr. Jeffrey Weber, MD, PhD is a member of this conference's faculty, and will discuss Combination therapies in immunotherapy and targeted agents during Friday's session.
April 28, 2013
$PVCT Europe Bound
Peter leaves for Europe on Monday for business development activities, which may include meetings with some or all of prospective pharma partners, industry KOLs, potential investors and existing shareholders. This trip appears more focused on partners and partnerships.
April 26, 2013
Daiichi Sankyo: A Dark Horse Challenger to Big Pharma Buying $PVCT
Earlier this month I identified visits from Daiichi Sankyo in Tokyo spending many, many hours on the blog. Later, I confirmed visits from Daiichi's U.S. headquarters in Parsippany, New Jersey. I think Daiichi Sankyo is interested in a multi-faceted relationship with Provectus.
Plexxikon reported interim analysis of its MM Phase 3 trial for vemurafenib (Zelboraf) in January 2011. In February, the following month, the company announced it was being acquired by Daiichi Sankyo. When a corporate approaches a target, the dance generally begins with an introduction typically 3 to 6 months or more before an acquisition, if achieved, is announced. By this math, Daiichi may have begun speaking with Plexxikon around mid-2010. Plexxikon treated the Phase 3 trial's first patient in January 2010.
Daiichi, one could argue, acted aggressively. "Just a few months after Daiichi Sankyo Co. Ltd. purchased biotech Plexxikon Inc. of Berkeley, Calif., for nearly $1 billion, the Japanese pharmaceutical company is reaping the benefits. A drug developed by Plexxikon and now owned by Daiichi, vemurafenib, was approved for treating metastatic melanoma by the U.S. Food and Drug Administration, the company said Wednesday." (Source here)
Think about it. Daichii approaches Provectus before Moffitt's data has been presented at AACR in April. Before Provectus' contemplated pivotal MM Phase 3 trial is finalized -- where "finalization" means the receipt of the SPA -- and well before enrollment is commenced. That should come as no surprise because PV-10 is far superior to vemurafenib (Zelboraf) and has more multi-indication potential already (whereas vemurafenib did not).
Daiichi has the balance sheet to pay what Provectus desires. In 2008 Daiichi announced that it would pay up to $4.6 billion for a controlling stake in Ranbaxy Laboratories, one of the largest manufacturers of drugs in India; this deal valued all of Ranbaxy at $8.5 billion (a 31% premium to its stock market capitalization prior to the announcement).
Daiichi also has a Japanese cultural approach to M&A that might force Pfizer's hand. That is, it could push Pfizer to act because it has to act to protect an asset (Provectus) it values but heretofore has no impetus to acquire.
"Global studies of M&A point out that once executives dive into the transaction process, they often become so invested in the deal that they cannot pull out even when necessary. In most markets today, however, common wisdom prevails that being able to walk away is a hallmark of M&A sophistication. That notion is rare among Japanese practitioners of outbound M&A." (Source here)
"The demands of Japanese-style consensus building, requiring the hard-won agreement of many parties, make abandoning a deal particularly hard. The potential loss of face in such a decision makes participants reluctant to suggest it, even if the logic of proceeding is undermined by new information."
Daichii was agressive in acquiring Plexxikon, paying more for the company than anyone else offered or was willing to pay. From all accounts, the acquisition is or eventually should be accretive.
If Daiichi executives set their mind to licensing PV-10 (or PH-10) or acquiring Provectus, then Big Pharma (including, in particular, Pfizer) might lose the asset to the Japanese if they're not willing to counter bid.
Plexxikon reported interim analysis of its MM Phase 3 trial for vemurafenib (Zelboraf) in January 2011. In February, the following month, the company announced it was being acquired by Daiichi Sankyo. When a corporate approaches a target, the dance generally begins with an introduction typically 3 to 6 months or more before an acquisition, if achieved, is announced. By this math, Daiichi may have begun speaking with Plexxikon around mid-2010. Plexxikon treated the Phase 3 trial's first patient in January 2010.
Daiichi, one could argue, acted aggressively. "Just a few months after Daiichi Sankyo Co. Ltd. purchased biotech Plexxikon Inc. of Berkeley, Calif., for nearly $1 billion, the Japanese pharmaceutical company is reaping the benefits. A drug developed by Plexxikon and now owned by Daiichi, vemurafenib, was approved for treating metastatic melanoma by the U.S. Food and Drug Administration, the company said Wednesday." (Source here)
Think about it. Daichii approaches Provectus before Moffitt's data has been presented at AACR in April. Before Provectus' contemplated pivotal MM Phase 3 trial is finalized -- where "finalization" means the receipt of the SPA -- and well before enrollment is commenced. That should come as no surprise because PV-10 is far superior to vemurafenib (Zelboraf) and has more multi-indication potential already (whereas vemurafenib did not).
Daiichi has the balance sheet to pay what Provectus desires. In 2008 Daiichi announced that it would pay up to $4.6 billion for a controlling stake in Ranbaxy Laboratories, one of the largest manufacturers of drugs in India; this deal valued all of Ranbaxy at $8.5 billion (a 31% premium to its stock market capitalization prior to the announcement).
Daiichi also has a Japanese cultural approach to M&A that might force Pfizer's hand. That is, it could push Pfizer to act because it has to act to protect an asset (Provectus) it values but heretofore has no impetus to acquire.
"Global studies of M&A point out that once executives dive into the transaction process, they often become so invested in the deal that they cannot pull out even when necessary. In most markets today, however, common wisdom prevails that being able to walk away is a hallmark of M&A sophistication. That notion is rare among Japanese practitioners of outbound M&A." (Source here)
"The demands of Japanese-style consensus building, requiring the hard-won agreement of many parties, make abandoning a deal particularly hard. The potential loss of face in such a decision makes participants reluctant to suggest it, even if the logic of proceeding is undermined by new information."
Daichii was agressive in acquiring Plexxikon, paying more for the company than anyone else offered or was willing to pay. From all accounts, the acquisition is or eventually should be accretive.
If Daiichi executives set their mind to licensing PV-10 (or PH-10) or acquiring Provectus, then Big Pharma (including, in particular, Pfizer) might lose the asset to the Japanese if they're not willing to counter bid.
April 25, 2013
The Date $PVCT Will Be Acquired Is...
Getting a dramatic blog post title out of the way, three precedent transactions provide insight into the end-game (under certain circumstances or along one of several potential paths).
Precedent transaction #1: Plexxikon reported interim analysis of its MM Phase 3 trial in January 2011. In February, the following month, the company announced it was being acquired by Daiichi Sankyo. Transaction #2: BioVex commenced its MM Phase 3 trial in April 2010. In January 2011, Amgen announced it was acquiring BioVex, by which time the trial was about 90% enrolled.
Think about this information in the context of a PV-10 MM Phase 3 trial under SPA with the FDA commencing enrollment in mid-2013 (i.e., late-Q2 or early-Q3): Enrollment might take one or several quarters, and Interim analysis could be available 12 months after enrollment is completed (patients would be treated as enrolled).
Between somewhere in enrollment and interim analysis, after the SPA is received. Drawing out the numbers, the time frame to acquisition through the running of a Phase 3 trial, generally speaking, could be H2 2013 through H2 2014'ish. This back-of-the-envelope "time framing" examines a Phase 3 trial under SPA, with no benefit of an accelerated pathway to market (via accelerated approval or a more precise (shorter) SPA via breakthrough therapy designation).
Receiving an accelerated path to market through receipt of the breakthrough therapy designation -- either accelerated approval or a more precise (and thus shorter or faster) SPA -- certainly would change the timeframe. Of course, the rate limiting step here is clarity on timing and detail of the accelerated path.
Somewhere after the receipt of breakthrough therapy designation ("BTD") is announced, when and if BTD is achieved. Drawing out the numbers in this case, the time frame to acquisition could be H2 2013 through H1 2014'ish.
Precedent transaction #1: Plexxikon reported interim analysis of its MM Phase 3 trial in January 2011. In February, the following month, the company announced it was being acquired by Daiichi Sankyo. Transaction #2: BioVex commenced its MM Phase 3 trial in April 2010. In January 2011, Amgen announced it was acquiring BioVex, by which time the trial was about 90% enrolled.
Think about this information in the context of a PV-10 MM Phase 3 trial under SPA with the FDA commencing enrollment in mid-2013 (i.e., late-Q2 or early-Q3): Enrollment might take one or several quarters, and Interim analysis could be available 12 months after enrollment is completed (patients would be treated as enrolled).
Between somewhere in enrollment and interim analysis, after the SPA is received. Drawing out the numbers, the time frame to acquisition through the running of a Phase 3 trial, generally speaking, could be H2 2013 through H2 2014'ish. This back-of-the-envelope "time framing" examines a Phase 3 trial under SPA, with no benefit of an accelerated pathway to market (via accelerated approval or a more precise (shorter) SPA via breakthrough therapy designation).
Receiving an accelerated path to market through receipt of the breakthrough therapy designation -- either accelerated approval or a more precise (and thus shorter or faster) SPA -- certainly would change the timeframe. Of course, the rate limiting step here is clarity on timing and detail of the accelerated path.
Somewhere after the receipt of breakthrough therapy designation ("BTD") is announced, when and if BTD is achieved. Drawing out the numbers in this case, the time frame to acquisition could be H2 2013 through H1 2014'ish.
There's yet another way to look at Provectus' endgame, too. Transaction #3: Bristol Myers acquired Medarex on the basis of the latter's MM Phase 2 data and a strong understanding of ipilimumab's mechanism of action. Dr. Jeffrey S. Weber, MD, PhD of Moffitt Cancer Center was highly involved in the elucidation of ipi's anti-tumor response. Dr. Weber also did translational research on vemurafenib (Zelboraf), Plexxikon's drug that was acquired by Daiichi Sankyo.
Soon? Drawing out the numbers in this case, the time frame to acquisition could be the end of 2013.
Provectus will be acquired when it is acquired. I found it helpful to review some precedent transactions in order to understand where the company currently resides in the bigger scheme of things.
Soon? Drawing out the numbers in this case, the time frame to acquisition could be the end of 2013.
Provectus will be acquired when it is acquired. I found it helpful to review some precedent transactions in order to understand where the company currently resides in the bigger scheme of things.
April 24, 2013
Just Put Some [of $PVCT's] PH-10 On It
I am, of course, relentlessly bullish on rose bengal, and thus PV-10 and PH-10; in the case of PH-10 for inflammatory skin disorders, a topical agent with what appears to be a very high or, literally, no dosing limit.
Peter said "We are pursuing translational research with PH-10 comparable to that underway with PV-10 to clarify the regulatory and commercialization pathways of PH-10."
Translational research? As we saw with Moffitt's work (among others, including Provectus'), answers were provided to questions about PV-10, such as how does PV-10 do what it does, or what is PV-10's clinical relevance -- how and when do you use the drug. Very effective. Very safe. Regular, frequent use. Locoregional monotherapy. Systemtic benefit. Anti-tumor immunity. Tumor-specific immunity. Combination therapy for inaccessible tumors.
By doing this translational research work, Moffitt provides Provectus with a key piece of data, information and knowledge to convince the FDA of PV-10's benefit and explain the drug's clinical relevance to Big Pharma. Both drive value.
Derived from the same active ingredient, why would one think any differently of PH-10? Such translational work is being done at a world-renowned university in a laboratory whose head has a world-class reputation with the FDA. I connected the dots. This work may well be completed by now, or it may soon be completed.
April 23, 2013
$PVCT: PV-10 + Radiotherapy by Foote et al.
Recall the combination of PV-10 + radiotherapy: Foote et al.'s initial and ongoing work combining PV-10 and radiotherapy are showing dramatic improvement for patients with much later stage disease (Stage IV) and heavy tumor burden.
A recent article on Princess Alexandra Hospital (Australia) radiation oncologist Dr. Matthew Foote, MD highlighted stereotactic body radiation therapy, where radiation is delivered at sub-millimeter precision (1 millimeter is equal to about 4 hundredths of an inch) to treat cancerous tumors while minimizing harm to normal tissue. By beng precise in its direction, Dr. Foote is able to "...crank up the dose of radiation." Craig historically has held the view that other drugs killed cancers through toxicity rather than tumor tissue specificity, and thus had poor efficacy and problematic side effects. The drugs killed normal tissue, leaked out and systemically poisoned patients, preventing the proper and effective stimulation of the immune system. It is interesting to note "targeted radiotherapy" is better than less precisely delivered radiotherapy.
In the article, Dr. Foote is quoted as saying "There’s evidence that the body’s immune system can fight melanoma so a high radiation dose can actually help stimulate the patient’s immune system to then fight off the melanoma."
Also recall the work by Tan and Nehaus: "Novel use of Rose Bengal (PV-10) in two cases of refractory scalp sarcoma." In the two cases highlighted by the authors, the approach was backwards. Yet, the “backwards” approach yielded good results on refractory sarcoma. Why backwards? Recall Foote et al.’s past and current work: PV-10 first, followed by radiotherapy. That appears to be the right treatment order.
Perhaps Dr. Foote will try PV-10 first, followed by targeted radiotherapy.
When Provectus provided an update about Dr. Foote's PV-10 + radiotherapy trial in October 2012, 7 subjects were enrolled.
Around January 2013, it appeared at least 10 patients have been treated, a follow-up to the success of their initial work on 3 patients.
I gather [but not from the company] half of the contemplated 30-patient trial has been enrolled.
A recent article on Princess Alexandra Hospital (Australia) radiation oncologist Dr. Matthew Foote, MD highlighted stereotactic body radiation therapy, where radiation is delivered at sub-millimeter precision (1 millimeter is equal to about 4 hundredths of an inch) to treat cancerous tumors while minimizing harm to normal tissue. By beng precise in its direction, Dr. Foote is able to "...crank up the dose of radiation." Craig historically has held the view that other drugs killed cancers through toxicity rather than tumor tissue specificity, and thus had poor efficacy and problematic side effects. The drugs killed normal tissue, leaked out and systemically poisoned patients, preventing the proper and effective stimulation of the immune system. It is interesting to note "targeted radiotherapy" is better than less precisely delivered radiotherapy.
In the article, Dr. Foote is quoted as saying "There’s evidence that the body’s immune system can fight melanoma so a high radiation dose can actually help stimulate the patient’s immune system to then fight off the melanoma."
Also recall the work by Tan and Nehaus: "Novel use of Rose Bengal (PV-10) in two cases of refractory scalp sarcoma." In the two cases highlighted by the authors, the approach was backwards. Yet, the “backwards” approach yielded good results on refractory sarcoma. Why backwards? Recall Foote et al.’s past and current work: PV-10 first, followed by radiotherapy. That appears to be the right treatment order.
Perhaps Dr. Foote will try PV-10 first, followed by targeted radiotherapy.
When Provectus provided an update about Dr. Foote's PV-10 + radiotherapy trial in October 2012, 7 subjects were enrolled.
I gather [but not from the company] half of the contemplated 30-patient trial has been enrolled.
$PVCT: HCC & PV-10
Since then, we've heard no word until recently, a few days ago, when a second site was opened: The Southeastern Center for Digestive Disorders & Pancreatic Cancer. The principal investigator is Dr. Alexander Rosemurgy, MD.
Problematic with running clinical trials, it seems, and among other things, is slowness on the part of the site and investigator to enroll and treat patients. With the opening of a second site, I hope this process is sped up. I imagine Provectus will issue a PR about the site when it enrolls and treats its first patient.
I am curious to understand whether the company has to enroll and treat all of the contemplated patients in the HCC expanded Phase 1 trial, or whether Provectus can enroll and treat a partial number in order to eventually submit an application for breakthrough therapy designation for PV-10 for HCC.
April 22, 2013
$PVCT: The Southeastern Center for Digestive Disorders & Pancreatic Cancer (2nd Liver Cancer/HCC Trial Site)
The website of The Southeastern Center for Digestive Disorders & Pancreatic Cancer can be found here. The principal investigator is Dr. Alexander Rosemurgy, MD. As a side note, Dr. Paul Toomey, MD of Moffitt fame (he was quoted several times related to Moffitt's poster at SSO in March 2012 when the cancer research center first concluded publicly that "Intralesional PV-10 Treatment Leads to the Induction of Anti-Tumor Immunity") appears to be doing a fellowship at The Southeastern Center (see below).
An Inflection Point in $PVCT Data
We finally may have reached the long-awaited inflection point in Rose Bengal data (PV-10 & PH-10).
Management thinks 2013 marks a turning-point in how Provectus is regarded by the FDA, Big Pharma and medical community key opinion leaders (KOLs) vis a vis "the data:" MM Phase 1 & 2, Breast Phase 1, HCC/liver Phase 1, inflammatory skin disorder Phase 1/2, Moffitt murine model immunology, Provectus murine model combination therapy, and the compassionate use program.
That's not to say more data is not very desirable: MM Phase 3 (if necessary), breast Phase 2, pancreas Phase 1, skunk works success by Craig with another key indication, Moffitt human immunology, and Moffitt-like immunology (and also toxicity) investigational work into PH-10 by a world-renowned university whose laboratory head has a world-class reputation with the FDA.
Management thinks 2013 marks a turning-point in how Provectus is regarded by the FDA, Big Pharma and medical community key opinion leaders (KOLs) vis a vis "the data:" MM Phase 1 & 2, Breast Phase 1, HCC/liver Phase 1, inflammatory skin disorder Phase 1/2, Moffitt murine model immunology, Provectus murine model combination therapy, and the compassionate use program.
That's not to say more data is not very desirable: MM Phase 3 (if necessary), breast Phase 2, pancreas Phase 1, skunk works success by Craig with another key indication, Moffitt human immunology, and Moffitt-like immunology (and also toxicity) investigational work into PH-10 by a world-renowned university whose laboratory head has a world-class reputation with the FDA.
April 21, 2013
$PVCT Files Pre-14A (Proxy Statement)
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Regarding proposal number 2, management is seeking shareholder approval for "...an amendment to our Restated Articles of Incorporation...to increase the number of shares of common stock...that we are authorized to issue from 200,000,000 to 250,000,000 shares."
The company, on a fully diluted basis -- common stock + preferred stock + common stock options + common stock warrants -- is nearing its threshold of authorized shares. The proxy counts this figure as about 188 million (see page 29).
I support Proposal No. 2 because it enables management to have sufficient shares of which to use, in part, to raise money so as maintain accounting firm BDO's going concern opinion in the event expected milestones (i.e., SPA, BTD-AA) do not raise the share price sufficiently to utilize the shelf in a less than punitive manner or upfront/cash payments (i.e., China, India, Japan, global, PH-10) from contemplated license deals do not materialize in a suitably soon time frame (i.e., when or should the remaining 12 million units run out or be insufficient).
$PVCT: Good Day, eh!
April 20, 2013
$PVCT: The End of the Regulatory Path is Gaining More Clarity
The regulatory journey on which the company has embarked appears to me to have two paths, which are not mutually exclusive nor unrelated. The paths also provide insight into the timing or catalysts for when Big Pharma might move on the Provectus.
The SPA. See recent related posts here (Current SPA Guidance) and here (Time Taken for the SPA). Current management guidance on the receipt of the SPA appears to be Q2. With Moffitt MOA and Provectus combination therapy results in hand, both demonstrating systemic potential, all that should be needed by Pfizer or other Big Pharma to buy Provectus would be interim MM Phase 3 trial data. Recall in BioVex's case, Amgen moved on the company when OncoVex demonstrated systemic potential and interim MM Phase 3 trial data was available.
BTD. A much more catalytic outcome when the end of this path is reached, there's work to be done here. Management (i.e., Eric and his team) must file the application (i.e., make the request) for BTD with the FDA. This scenario could play out like this: The FDA grants Provectus BTD for PV-10. An accelerated path to market in a manner similar or equal to accelerated approval materializes. The SPA, should it be received prior to BTD being granted, is turned into as a post-marketing study (Phase 4 trial). Pfizer or another Big Pharma buys the company thereafter.
The SPA. See recent related posts here (Current SPA Guidance) and here (Time Taken for the SPA). Current management guidance on the receipt of the SPA appears to be Q2. With Moffitt MOA and Provectus combination therapy results in hand, both demonstrating systemic potential, all that should be needed by Pfizer or other Big Pharma to buy Provectus would be interim MM Phase 3 trial data. Recall in BioVex's case, Amgen moved on the company when OncoVex demonstrated systemic potential and interim MM Phase 3 trial data was available.
BTD. A much more catalytic outcome when the end of this path is reached, there's work to be done here. Management (i.e., Eric and his team) must file the application (i.e., make the request) for BTD with the FDA. This scenario could play out like this: The FDA grants Provectus BTD for PV-10. An accelerated path to market in a manner similar or equal to accelerated approval materializes. The SPA, should it be received prior to BTD being granted, is turned into as a post-marketing study (Phase 4 trial). Pfizer or another Big Pharma buys the company thereafter.
$PVCT: More Proactivity by the FDA
The Medical Technology Stock Letter wrote Thursday about Pharmacyclics (NASDAQ: PCYC):
ahead of anyone's expectations by a material pace. Doesn't it appear the FDA has gotten behind PCYC in a big way.
How much is the FDA behind Provectus and PV-10?
"Last night, Janssen (in conjunction with Pharmacyclics) filed a Phase 4 Open Label Treatment Protocol for patients with relapsed/refractory mantle cell lymphoma (MCL) on www.clinicaltrials.gov. This early access program (EAP) is designed to allow use of single-agent ibrutinib to treat RR MCL patients that have no option and cannot enroll in a clinical trial. Currently, there are no RR MCL studies with ibrutinib underway - there is only a front-line MCL trial that is still enrolling patients. Traditionally, a pharmaceutical company, such as JNJ, will open an EAP within 2-3 months of filing for approval with the FDA. Therefore, we now expect that the ibrutinib filing will occur in Q3:13, approximately 3-6 months ahead of the year-end, publicly scheduled BLA. We believe that the FDA Breakthrough Therapy Designation (BTD) is, therefore, moving quickly along, and that formal approval will occur before the end of 2013 - roughly 6-9 months ahead of consensus expectations. In our view, this is a major positive for Pharmacyclics and is not discounted into any Wall Street forecasts, even the most bullish of opinions. We expect the consensus timing and estimates will rise as soon as this information is further disseminated. We had believed ibrutinib would be approved in early 2014, ahead of anyone on the Street. Based upon this new early access program and related timing of events, it seems that even we were too conservative."The key takeaway is bolded. Note the framing of "6-9 months ahead of consensus expectations." It would seem because of breakthrough therapy designation, Pharmacyclics' process is moving well
ahead of anyone's expectations by a material pace. Doesn't it appear the FDA has gotten behind PCYC in a big way.
How much is the FDA behind Provectus and PV-10?
April 19, 2013
$PVCT: Some Additional Analysis Regarding Today's 8K (Fund raising)
I went through the recent calendar year 2012-related 10-Q & 10-K, and produced the table below:
The output (last line) is the company's cash monthly burn rate, per quarter, for 2012. Provectus issues stock and warrants for services rendered, and there also are additional non-cash items. I think I'm on the mark, but I am open to being corrected.
According to Peter, the raise announced in the 8-K filing today was related to ensuring BDO continues to provide the company with a going concern opinion, which is reviewed every quarter-end. For purposes of how BDO assesses Provectus' ongoing operations, the company requires ~$4 million at any given time of assessment.
Hence, prior to year-end, as you read the 2012 10-K, the company raised net proceeds of $2.28 million (not reflected on the 2012 year-end balance sheet in the K) to near this rough or soft $4 million threshold.
You can see this in the table below, under Q4-12: Cash and cash equivalents, at end of period.
Using recent historical quarterly cash burn amounts, I constructed the table below. This table assumes an approximate $930K burn per month.
And below. This table assumes a $750K burn per month:
The takeaway here is management probably won't fall sufficiently below the necessary threshold (again, I think it is a soft or rough one) through the end of Q2 (the end of June), assuming expenses don't shoot up for some expected or unreasonable reason, to endanger BDO's going concern opinion.
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| Click on table to enlarge in separate window |
According to Peter, the raise announced in the 8-K filing today was related to ensuring BDO continues to provide the company with a going concern opinion, which is reviewed every quarter-end. For purposes of how BDO assesses Provectus' ongoing operations, the company requires ~$4 million at any given time of assessment.
Hence, prior to year-end, as you read the 2012 10-K, the company raised net proceeds of $2.28 million (not reflected on the 2012 year-end balance sheet in the K) to near this rough or soft $4 million threshold.
You can see this in the table below, under Q4-12: Cash and cash equivalents, at end of period.
Using recent historical quarterly cash burn amounts, I constructed the table below. This table assumes an approximate $930K burn per month.
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| Click on table to enlarge in separate window |
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| Click on table to enlarge in separate window |
April 18, 2013
$PVCT Files 8-K. Raises $3.3MM.
Provectus made an 8-K filing to announce it raised $3.3 million through today. Not adjusted for exercises, there appears to be about 190 million fully diluted shares outstanding (after consideration for preferred and common stock, options and warrants).
April 17, 2013
$PVCT: A Proactive FDA
Ripples become waves. It takes time. It also takes a ripple.
Entitled "A Proactive FDA Is Already Reviewing Sarepta's Muscular Dystrophy Drug (Updated)," Adam Feuerstein recently wrote about the FDA actively reviewing the efficacy and safety of Sarepta Therapeutics' Duchenne muscular dystrophy drug eteplirsen even though the drug has not been formally filed for approval.
In his article, Feuerstein writes "Baird analyst Brian Skorney gets it. "On the surface it appears that the FDA is requesting information that would normally be part of the NDA review process," he writes in a research note. "This appears to be a bit of a departure from precedent and shows the FDA's willingness to remain flexible (at least publicly) on this review. We believe that the agency is essentially doing the bulk of the review on this application prior to submission and would view a recommendation by the agency to file based on the available data as a very strong indication that it will result in an approval.""
Feuerstein further writes "Why is this good news, again? Because the FDA could have easily told Sarepta to come back with data from the planned phase III study. That would have told us FDA didn't believe the existing eteplirsen data."
In its equity research update note Neuralstem Receives Phase 2 ALS Trial Approval, Aegis Capital wrote about this company receiving approval from the FDA to begin Phase 2 testing of its neural stem cell line therapeutic, designated NSI-566, in patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.
The analysts wrote "FDA Giving Neuralstem What They Wanted. We note that the regulatory agency provided Neuralstem with the approval that the firm requested to begin testing substantially higher doses of NSI-566, which we consider a crucial step forward."
The FDA provides regular updates on submissions and actions taken (within the prescribed time frame) for breakthrough therapy designation (BTD).
When I speak with Pete about the regulatory path, he consistently describes Eric and his team's relationship with the FDA as accommodative.
In regards to Provectus, I think a proactive FDA would:
Entitled "A Proactive FDA Is Already Reviewing Sarepta's Muscular Dystrophy Drug (Updated)," Adam Feuerstein recently wrote about the FDA actively reviewing the efficacy and safety of Sarepta Therapeutics' Duchenne muscular dystrophy drug eteplirsen even though the drug has not been formally filed for approval.
In his article, Feuerstein writes "Baird analyst Brian Skorney gets it. "On the surface it appears that the FDA is requesting information that would normally be part of the NDA review process," he writes in a research note. "This appears to be a bit of a departure from precedent and shows the FDA's willingness to remain flexible (at least publicly) on this review. We believe that the agency is essentially doing the bulk of the review on this application prior to submission and would view a recommendation by the agency to file based on the available data as a very strong indication that it will result in an approval.""
Feuerstein further writes "Why is this good news, again? Because the FDA could have easily told Sarepta to come back with data from the planned phase III study. That would have told us FDA didn't believe the existing eteplirsen data."
In its equity research update note Neuralstem Receives Phase 2 ALS Trial Approval, Aegis Capital wrote about this company receiving approval from the FDA to begin Phase 2 testing of its neural stem cell line therapeutic, designated NSI-566, in patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.
The analysts wrote "FDA Giving Neuralstem What They Wanted. We note that the regulatory agency provided Neuralstem with the approval that the firm requested to begin testing substantially higher doses of NSI-566, which we consider a crucial step forward."
The FDA provides regular updates on submissions and actions taken (within the prescribed time frame) for breakthrough therapy designation (BTD).
When I speak with Pete about the regulatory path, he consistently describes Eric and his team's relationship with the FDA as accommodative.
In regards to Provectus, I think a proactive FDA would:
- Suggest the company consider submitting a request for BTD,
- Grant Provectus BTD for PV-10 for use in the expanded label of recurrent and metastatic melanoma (the focused label being sought for PV-10 under the SPA is metastatic melanoma in Stage III patients),
- Accelerate PV-10's path to market, in a manner similar to granting the drug accelerated approval, and
- Permit the trial design, including progression definition and programmatic element work, the company currently is utilizing in seeking the SPA to be used as a post-marketing study.
"Accommodative" probably works well for now. "Proactive" will be appropriate in Provectus' case (with the benefit of hindsight, of course) whenever the company achieves the above.
Adam's Feuerstein's description of a "proactive FDA" may continue to ripple until the number of Agency's like actions causes a wave of awareness of its seemingly new behavior and assistance to patients, drugs and companies.
$PVCT: Maxim At It Again
They're baaack... Is Maxim soliciting some Provectus shareholders to become clients and open accounts with the broker-dealer, again? From what I gather, the pitch comes right out of the movie Boiler Room. Maxim folks suggest marks, er, people to whom they speak open an account with the firm so as to give them (the marke, er, those targeted, er, called) favored status when Provectus next fund raises like the company did in February. Why buy in the open market when you can get a sweeter deal (stock + warrants) courtesy of your friends at Maxim? A small dog -- let's call him Seth -- purportedly calls the mark, er, prospective client. Then, purportedly, a bigger dog -- let's call him, um, Chris -- jumps on the phone to try and close the deal.
Update (4/17/13): Some readers of the blog have e-mailed both the company and me asking about this post. They are concerned Maxim is calling some shareholders because Provectus is raising money and, thus, no deal of any kind (e.g., China, India, Japan, global license, PH-10) is in the cards. Peter communicated to me the company has no relationship with Maxim in regards to any fund raising. It appears to me Maxim folks simply are prospecting for business, and are using their firm’s historical association with Provectus (i.e., equity research coverage, primary book-runners on the now terminated PVCTP “IPO”) as the starting point of the conversation. As far as I know, Provectus is not fund raising at the current time.
Strangely, I have not been called.
Update (4/17/13): Some readers of the blog have e-mailed both the company and me asking about this post. They are concerned Maxim is calling some shareholders because Provectus is raising money and, thus, no deal of any kind (e.g., China, India, Japan, global license, PH-10) is in the cards. Peter communicated to me the company has no relationship with Maxim in regards to any fund raising. It appears to me Maxim folks simply are prospecting for business, and are using their firm’s historical association with Provectus (i.e., equity research coverage, primary book-runners on the now terminated PVCTP “IPO”) as the starting point of the conversation. As far as I know, Provectus is not fund raising at the current time.
Strangely, I have not been called.
$PVCT: Time Taken for the SPA
I tried to piece together the history, as much as I understand it, of the time taken to pursue the SPA.
The company's October 2, 2012 PR elucidates the progression definition and programmatic element work that comprise some of the time taken.
Progression definition work. "Progression Free Survival (PFS) will serve as the primary endpoint, with progression defined to include increased tumor burden, advent of active nodal disease, onset of distant metastasis and symptomatic deterioration based on validated instruments."
Programmatic element work. "We have also completed detailed operational planning, something which the FDA now frequently expects as part of the SPA package and a critical step to assure that the study runs smoothly."
The systemic benefit validation, provided by both Moffitt and Provectus' PRs, does not relate to the process of finalizing the SPA with the FDA, although it coincides with the timing of when SPA should be finalized. Of greater interest, and the topic of a subsequent post, that same systemic benefit understanding provides the springboard to a breakthrough therapy designation (accelerated approval) this year.
The company's October 2, 2012 PR elucidates the progression definition and programmatic element work that comprise some of the time taken.
Progression definition work. "Progression Free Survival (PFS) will serve as the primary endpoint, with progression defined to include increased tumor burden, advent of active nodal disease, onset of distant metastasis and symptomatic deterioration based on validated instruments."
Programmatic element work. "We have also completed detailed operational planning, something which the FDA now frequently expects as part of the SPA package and a critical step to assure that the study runs smoothly."
The systemic benefit validation, provided by both Moffitt and Provectus' PRs, does not relate to the process of finalizing the SPA with the FDA, although it coincides with the timing of when SPA should be finalized. Of greater interest, and the topic of a subsequent post, that same systemic benefit understanding provides the springboard to a breakthrough therapy designation (accelerated approval) this year.
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