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Re: DewDiligence post# 8366

Wednesday, 03/02/2005 11:38:03 AM

Wednesday, March 02, 2005 11:38:03 AM

Post# of 257265
Yeah, I was very pleased with the CC which assuaged my negativity expressed in earlier posts today.

I tried to post twice on Yahoo, but the messages seem to be lost in cyberspace.

The biggest encouraging news for me is the details on ATryn study design. Those seem to be major concessions from an FDA under pressure to assure scientific rigor more than ever. I am not against rigorous study design, but this is a case to soften the requirements considering these factors:
* Double blind placebo controlled studies can not be done properly;
*large numbers of study patients are not needed because the disease is quite predictable;
*the mechanism of action of the drug is understood;
*and the drug itself is almost tantamount to a natural replacment therapy.

Apparently Cox also read my earlier comments on IHub and went out of his way to mention Merrimack and Centocor which also pleased me. He made it very clear, however, that he has no information or guidance on Merrimack.

Thanks for asking the questions on the CC, Dew

Urche


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