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Biotech / Medical : Biocryst Pharmaceuticals Inc (BCRX)

BCRX 7.385

-3.1%

Jan 9 9:30 AM EST

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From: Ian@SI	9/20/2007 12:31:19 AM
	Read Replies (3) of 269

Just listened to the BCRX cc replay. If one just listens to Stonehouse, you'd be left with the impression that the PhII was successful meeting or exceeding expectations (He did acknowledge that stat sig wasn't attained even when one looked at those pts getting an adequate IM dosage. Due to insufficient n.) 1. No reason for changing needle size from ph 1 was provided (said it was more pt friendly) 2. Cited several research studies clearly proving needle size was vital. Why in hell didn't he and all the clinical staff know this before the trial failed? 3. Thinks the FDA will have no real hangups with BCRX proceeding directly to PHIII. That when they look at the high CK (Creatine Kinase) group, both safety and efficacy signals were present. I'm out of my depth here, but I think it's premature to rule out being required to do another PhII and possibly delaying Peramivir availability by a calendar year. It seems to me that they just shouldn't have screwed up in this fashion; that they shouldn't have had to rediscover what was already well known; and, I don't know why I should trust them to do better next time. Any opinions out there????

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