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Biotech / Medical : GTXi (GTXI)

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To: kenhott who wrote (68)	11/2/2009 11:42:41 AM
From: kenhott	Read Replies (1) of 85

<reply> I did get a chance to listen to the cc. The FDA basically threw the SPA out the window and the 80mg program is I believe done because I don't know if it makes sense to run another phase 3 trial (It will be another 5 year trial with costs of ~$35M). I would almost think that if they run another trial, it would give me a hint at their confidence re: the other programs. I don't know, that maybe too cute of a thought. The HGPIN data will be 1Q 2010ish and it also has an SPA. It is also one trial only but with a p<.01 hurdle so not likely the FDA will ask for another trial in that case. The HGPIN program is a high risk/high returns program. GTXI will have a Type A meeting with the FDA and will get a more complete answer from the FDA before end of 2009. The market maybe hoping right now that the 80mg program is not dead. But later the market may not be that happy if GTXI continues to push money into this program either. As far as I know, the EU filing has not been done yet. Once I get out of my current position, I need to figure out how to position for the PIN data. edit: <wilder> Smart and sane people don't invest in bio stocks. :)

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