Provectus's breakthrough therapy designation application was turned down by the FDA. The company issued a press release entitled Provectus Biopharmaceuticals Inc. Reaffirms Its Commitment to Bringing PV-10 to Market Notwithstanding FDA Decision on Breakthrough Therapy Designation. The associated SEC 8-K filing is here. The included FDA letter response or notice is here.
More analysis and commentary to follow.
Updated (5/24/14): The Memorial Day long weekend here in the U.S. provides an opportunity to spread my writing, analysis and commentary over several days (stock markets are closed on Monday). I want to digest Friday's news, collect more information, and prepare for Tuesday and presumably the rest of next week's likely substantial volatility in the share price (the stock did not open for trading yesterday). Topics should include Provectus' conference call* (and the FDA response letter), management credibility, pathways to approval, risks, the state of my investment thesis, my estimation of worth, and others.
* "A digital replay will be available by telephone approximately two hours after the completion of the call until July 23, 2014, and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, and using the Conference ID#13583661."