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Biotech / Medical : Provectus Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?

To: pincus who wrote (12130)	6/28/2013 2:16:20 PM
From: NTTG	Read Replies (1) \| Respond to of 13111

Odd......FDA is getting a lot done with other drugs, why so 'disorganized' (or disinterested) when it comes to PV-10? Maybe the confusion is not with the FDA? This is definitely a drug that will need a long shelf life, for all the anticipated approval delays and low commercial use it will get in the west...of course, given poor access to refrigeration in China, that could be a plus...some day - no time table = continued delays for MM PIII approval - simple narrow approval = stage III only; the hope that off label use will build their market is a poor commercial business plan Emphasis on HCC in the Pacific Rim sets the company $ for development back to PI stage...where is progress on PH-10? Diminished emphasis on BTD is probably a good reality check Sounds like popcorn impresses the group a lot more than RB does...the problem here is there are no knowledgable parters involved with shepherding this company through next steps......bet next years refreshments are even thriftier than this years..... and now you know why SP continues to decline...smoke screen...they are working all the angles, for sure

To: pincus who wrote (12130)	6/28/2013 6:13:21 PM
From: boomertree2	1 Recommendation Recommended By Rutgers Respond to of 13111

There have been no delays caused by the FDA reorganization. The FDA reorganization had its intended affect of expediting approvals, and the recent record of FDA approvals bears this out.....see my email below from a couple weeks ago. New Melanoma Treatments Bring FDA Approval Tally To 13. Reuters (5/31, Hirschler, Berkrot) reports that the US Food and Drug Administration’s statement Wednesday announcing it approved two of GlaxoSmithKline’s new oral treatments for metastatic or unresectable melanoma – Tafinlar (dabrafenib) and Mekinist (trametinib) – brings the total number of new drugs approved this year to 13, whereas around the same time last year, the agency had approved 11 new medications. Overall in 2012, the FDA approved 39 new treatments, representing the most drug products cleared by the agency since 1996. FDA moving more quickly on new drug approvals, but PVCT management can't get a phase III protocol approved 3 years after end of phase II trials. Management exceptional......yes, exceptionally bad. The only material change since the end of the phase II trial is that we now have less money to fund the phase III trial since management has been paying itself millions every year for no measurable progress.