The FDA turned down Provectus BioPharmaceuticals' (PVCT) request to grant Breakthrough Therapy Designation (BTD) to its experimental skin cancer drug PV-10.
Of course. I told you this BTD rejection was going to happen last January. Being right about the obsolescence of PV-10 doesn't make me especially prescient, it just means I'm sane.
Here's the key line from the letter sent to Provectus by the FDA. Please, everyone, pay attention:
FDA previously communicated concerns regarding the development program and provided advice regarding the type of data that should be systematically collected to investigate the clinical benefit(s) of an intratumoral treatment of a subset of individual lesions in a systemic disease (malignant melanoma), as previously discussed at the April 8, 2010, March 7, 2011, and October 18, 2011, end-of-Phase 2 meetings and the December 16, 2013 General Guidance teleconference.
10/14/15 - 11:47 AM EDT
05/19/15 - 04:42 PM EDT
05/19/15 - 12:48 PM EDT
05/18/15 - 08:06 AM EDT
05/05/15 - 02:43 PM EDT
05/04/16 - 18:23 PM EDT
05/04/16 - 17:09 PM EDT
05/04/16 - 16:49 PM EDT
05/04/16 - 16:24 PM EDT
05/04/16 - 14:38 PM EDT
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
Trifecta Stocks analyzes over 4,000 equities weekly to find the elite 1% of stocks that pass rigorous quantitative, fundamental and technical tests.
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
Chris Versace, using sophisticated stock screening and fundamental research, identifies potentially explosive small and mid-cap stocks.
Master swing trader Alan Farley uses his sophisticated software screens to review thousands of stocks each day for you, to find just the handful that meet his demanding criteria.