A. "One measure which has been designed to mitigate some of this regulatory risk is the Special Protocol Assessment (SPA) agreement between a sponsor (often drug companies) and the Food & Drug Administration (FDA), which first issued guidance on the process in 2002."
B. SPA Takeaways.
Takeaway #1. Sponsors who have successfully conducted studies that have met the predefined outcomes in a SPA agreement are highly unlikely to be rejected on the grounds that more clinical data/studies are required. I think I now have a much better perspective on the time Eric took to hone the agreement with the FDA on the SPA. The SPA of course has not yet arrived, so nothing is final until it is final.
- The right barrel, for size, diameter, leakproof-ness, ability to withstand buckshot or bullets from the gun, etc.,
- The right gun, for accuracy, effectiveness, magazine size, power, etc.,
- The right liquid for the barrel, for clearness, low viscosity, etc.,
- The right fish for slowness, docility, easy identification, size, etc.,
- And so on until you had reduced possible degrees of freedom to a de minimis number.
The goal would be to leave nothing to chance. In doing so, I think Eric spent copious amounts of time and significant effort to ensure the eventual trial design would generate both a statistically significant and clinically meaningful outcome, even if it meant more time than initially expected to do so.
#2. PV-10 is safe.
Takeaway #3. Even the safest and most efficacious drugs can be held up if there are issues with the CMC component of the NDA. I have not discussed much of this aspect of the PV-10, but my diligence thus far suggests there are no significant CMC (Chemistry, Manufacturing and Control) hurdles.
Takeaway #4. The path from SPA to approval can typically take upwards of 5 years. A interesting point, particularly in light of the time it took Provectus to enroll, treat, analyze, and release interim, preliminary and final clinical data of patients in the company's MM Phase 2 trial. Contrast this with management's belief the control arm of the MM Phase 3 trial data should fail in 1-2 months, interim analysis may be available as early as late-Q3 or Q4 2013, and PV-10 could be approved as early as 2014.