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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.0600+16.5%3:10 PM EST
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To: travisnye who wrote (11409)7/3/2012 8:29:58 AM
From: NTTG2 Recommendations  Read Replies (1) of 13111
 
The clear observation from the FDA discussions to date is that PVCT came up short; they did not sell the PV-10 story for aggressive MM, and will have to accept the fall back position. The position echo's the prior consolation that the next step HCC studies will have to be done in combination with sorafenib, not PV-10 monotherapy. In both cases, PVCT has not convinced the FDA that the risk of PV-10 is worth it.

The concern with the attenuated severity patient population proposed for PIII MM trials is that it favors both arms. The PFS primary end point is easier for conventional therapy to achieve in slow progression disease state, the additional 'kicker' of the proposed bystander effect may get lost in the noise of the smaller patient population. If I design a new engine for Ferrari, the last place I want to demonstrate what that engine can do is by driving the car in a 35 MPH speed zone, no one is pushed to the performance limit there.

Since the company has offered no prior comparator controlled data for MM, there is a real coin toss now as to whether PV-10 will eek out an advantage. The PIIb trial data will be telling, failed evidence for a consistent/robust immune response will not bode well for PV-10 in a PFS focused trial.

Have been lucid all along
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