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Microcap & Penny Stocks : Pharmos(PARS)
PARS 2.700+13.6%Jan 21 4:00 PM EST
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To: NeuroInvestment who wrote (1378)10/10/1998 12:10:00 AM
From: Rick Strange  Read Replies (2) of 1491
 
N.I. Let me take a shot at playing Madison Avenue: 'HU-211 triples the likelihood of returning to normal life style after sever head injury.' To paraphrase one of your comments: "Most people don't know what ICP is and don't care." They do understand a smashed head and the ability earn a living after a sever injury.

PARs may have been playing to the balcony when they stressed mortality. You wrote 5/10/98: "The FDA likes mortality endpoints because they are admittedly very easy to measure, there is generally good interrater reliability when it comes to determining if a patient is alive or dead, and that kind of binary categorical measure makes the statistics easier."

Since HU-211 addresses a previously untreatable condition would orphan drug status offer PARS any advantage either during trials and in the market place, assuming it is approved? Could treatment-IND status help lower the cost of trials? Is the ICP effect of HU-211 a valid "surrogate endpoint" that would allow the FDA to grant market approval? If the ICP effect and "good outcome" were valid endpoints and Phase III trials were limited to the more sever injuries (GSC 3-6 or 4-6) how large a patient population would you have to have, assuming a double blind placebo controlled trial? Same question but ICP only?

I find your comments very valuable and will subscribe to your newsletter.

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