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Replies to #12094 on Biotech Values
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DewDiligence

06/13/05 2:50 PM

#12098 RE: io_io #12094

>>That was the article I was referring to… safety…It mentions trends against safety…<<

io: Are we referring to the same text? What I cited was not an article but rather a section of GTCB’s 2001 10K SEC filing. I did not see any discussion of “trends against safety.” Please clarify.

>>And so are you "reaching" for your conclusion here, that the FDA did not like the way the trials were run ? Or do you have other hearsay?<<

No, I’m not reaching – I’ve read the old PR’s and have discussed the matter with Tom Newberry in IR.

>>…if CABG was the target in the late 90's; why would the target change ? to save $$$ ? hardly, the size of the original trials were not too large.<<

The change in indication from CABG to HD was to save time and money. The original CABG trials had 104 patients between them. The current U.S. ATryn trial in HD has 17 patients.

In short, details of the old CABG trials are interesting from a historical perspective but are not especially relevant to what GTCB to doing today. As I noted in the previous post, CABG is quite far down on the list of potential indications for ATryn. You will see CABG mentioned on some of the company’s presentation slides, but I highly doubt that CABG is an indication that the company will actively pursue in the next few years.