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Post# of 252218
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DewDiligence

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DewDiligence

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Re: DewDiligence post# 3067

Thursday, 08/05/2004 11:41:11 AM

Thursday, August 05, 2004 11:41:11 AM

Post# of 252218
Notes on today’s GTCB CC:

I would have preferred to hear that GTCB’s answers to the EMEA’s ATryn questions were ready to be submitted now, but I can live with a submission in Q4, as was promised on the CC.

What’s key is that the EMEA is not questioning the efficacy of ATryn; i.e., the EMEA has no problem with the two cases of DVT seen in the clinical trial. This had previously been my biggest concern in the EMEA’s review. It’s also reassuring that the EMEA is not questioning the safety of transgenically-derived proteins.

It sounds as though the EMEA’s questions largely concern characterization-of-product issues, and are routine in nature. [CEO] Cox stopped just short of guaranteeing that no additional clinical studies would be needed; I think he is just being conservative and wisely does not want to be seen as usurping the EMEA’s authority.

Other items of note from the CC:

--Cash on hand is sufficient to get into 2006. The company expects to have $25M on hand at the end of 2004 and to burn less than that in 2005. Hence, even if the EU ATryn launch were delayed slightly (from mid 2005 to later in the year), there would be sufficient money to fund operations. I expect that the company would want to raise more capital if it could be done at a much higher stock price, but there is no necessity to do so any time soon.

--The planned U.S. ATryn trial will likely cost less to conduct than the European trial because GTCB can benefit from some of the work already done for the European trial (presumably on the production end). A revised IND will be submitted to the FDA in the next three months (#msg-3735184).

--HSA qualification runs are expected by the end of 2004. There have been many inquiries from prospective customers. I consider the HSA program to be a substantial component of GTCB’s overall value.

--The sell-side analysts on the CC were David Wood (R&R) and Phil Nadeau (Cowen). Nadeau is one of the best in the biotech sector; I’m not sure about Wood.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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