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keitern

09/07/07 4:15 PM

#4959 RE: DewDiligence #4957

Do you think we would need a partner in the US to effectively market Atryn for HD? I wonder if, because of the fact that there is a shortage in the US, it would be easier to market than some other drugs with intense competition like Tyzeka, for example.
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Black_Knight_765

09/08/07 11:50 AM

#4967 RE: DewDiligence #4957

I assume that some of the following assumptions are incorrect and I would appreciate comments and corrections from more knowledgable participants to derive a realistic timeline.

Assumptions:

Atryn is approved by the FDA for HD in 4th qrtr 2008 or 1st qrtr 2009. It can go to market and GTCB should receive some revenue, but not enough to be profitable, in 2009 and 2010.

Phase II for DIC concludes successfully in 3rd quarter 2008.

Phase III for DIC begins early 2009 and completes early 2010.

DIC indication submission to FDA early 2010, approved by FDA late 2010.

Revenue from DIC sales in EU and US commence in 2011. Lead times for marketing are reduced because marketing already established for hd in 2010.

This timeline results in profitability in 2011.

High probability of continued losses, and further dilution, over the next four years, is the probable reason for the PPS to hover below $1.20

The investment situation will be different in 2nd quarter of 2009, or earlier, with the positive completion of Phase II for DIC and approval of Atryn for HD in US. At that time there would be the perception of a high probability of profitability in the 2 year time frame.

The PPS would greatly benefit if GTCB engages in a few revenue producing programs like Merrimac. But the deal with LFB had the opposite effect, increasing expenses and diluting the stock without any prospect for revenues for 6+ years.

I hold a large position and may add more at current prices, below $1.20, over the next year or so.