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Biotech / Medical : Pharmos (PARS)
PARS 2.700+13.6%Jan 21 4:00 PM EST
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To: Rick Strange who wrote (974)1/25/2000 10:21:00 AM
From: NeuroInvestment  Read Replies (3) of 1386
 
1) It should. But given the character of the FDA CNS Division, which is very inflexible, it won't. It would have greatly simplified trial design and reduced size/time required. But the FDA has made it clear to PARS that they will not accept ICP as the primary.
2) No. Partly because of the FDA issue noted above. Case in point: Interneuron's stroke drug failed its primary endpoint (improvement on the NIH stroke scale) but showed significant improvement on the secondary endpoint (improvement on Rankin scale). If they had simply designated the Rankin as the primary, the stroke trial would be deemed a success. But the FDA will not consider the secondary endpoint data from this 900 pt trial. For an equally untreated condition. Given that kind of attitude, HU211's Phase II trial isnt even in the ballpark.

NeuroInvestment (www.neuroinvestment.com)
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