Provectus Pharmaceuticals Inc. Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Provectus Pharmaceuticals Inc.

PVCT 0.0600

+16.5%

Nov 26 3:10 PM EST

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

From: NTTG	6/27/2012 6:37:57 AM
	1 Recommendation Read Replies (1) of 13111

Looks like the proposed study population dropped from ~300 to ~180 subjects because PVCT will no longer be including stage IV patients, where PV-10 is clearly less effective. Likely won't include patients with rapidly progressive disease (post-hoc elimination of 11/80 patients), a move that also makes a positive response more likely. The predicted post hoc editing has weeded out the 'hard to treat' patients for the proposed PIII protocol. Of course...it also increases the odds that the comparator arm will look good too. Don't need to expose as many people to a potential risk when only looking at slow progressing stage III patients. Patient selectivity, final dosing strategy (which may wind up with a staggered dose schedule with a roll in and max dose limits), and definition of PFS (any added therapy or cross over strategy is generally considered a failure in an intent to treat protocol design, but can be followed for secondary end points and overall safety analysis) are still not defined. My bet...PVCT wanted to keep the stage IV patients in the study design, but after 2 years of FDA negotiations finally agreed to limit the patient scope to vanilla stage III cases.

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next