Followers | 25 |
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Alias Born | 10/18/2003 |
Wednesday, December 29, 2004 11:09:06 PM
This means Phase I data if available by November IMO.
Terry, have you had any thoughts about why the FDA is so concerned about Tarvacin's MOA? I have. I have been doing some research on antiphospholipids. So far it appears that too many of these antibodies can cause thrombosis. I think the FDA has concerns about Tarvacin causing thrombolytic events, and Dr. Thorpe, Sherris, King, Schroit etc are encountering resistance from the FDA about antiphospholipids being associated with blood clotting.
So if Tarvacin is to be systemically administered, as hopefully planned, do they have the animal data available to prove to the FDA the drug will not cause thrombolytic events in humans? Have they REALLY proven to the FDA Tarvacin will only effect blood vessels on tumors and NOT healthy organs where phospholipids thrive...exist?
It doesn't matter to me whether the website is updated with Thorpes presentation date, what matters is if PPHM has the clinical prowess to convince the FDA Gods Tarvacin will not cause any massive clots, strokes, thrombosis etc....
The latest S-3 prospectus suggests there are problems in negotiations with the FDA. There are varying interpretations of data. Varying meaning the FDA and Team PPHM. Who are the experts going to bat for Team PPHM? Why is the FDA holding up this mab?
If management cannot get this drug into Phase I, then it all makes sense why they are selling shares now to get cheaper options. Insiders always covers their buffs.
katie....
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