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Biotech / Medical : Pharmos (PARS) -- Ignore unavailable to you. Want to Upgrade?

To: Richard Huth who wrote (383)	1/2/1999 9:27:00 PM
From: Zvi Steinberg	Read Replies (2) \| Respond to of 1386

Here's an interesting post by Pillx copied from the PARS rhread on het.beleggers.net (Click on BeleggersNet Live towards the bottom of the page, then on PARS? to reach the thread) Most of the posts are in Dutch (Flemish), but Pillx posts in English. By PILLX on Saturday, January 2, 1999 - 01:46 am: In response to query regarding fast-tracking of HU211... There is no question that HU211 will qualify for fast track status, and expedited review (as dealing with life threatening condition. The FDA just last week released its revised standards for fast track, HU211 meets the standard with no problem. Thus a Phase III plan can be submitted with a request for fast track status--once approved, this means that the FDA will do a rolling review of materials as they come in, instead of waiting for the whole package to be assembled. A completed Phase III in TBI would lead to an NDA which would be responded to in six months or less. The intriguing aspect of the revised standards has to do with 'surrogate endpoints'--as is intracranial pressure. The new standards suggest that companies can obtain approval based on successfully meeting surrogate endpoints, then complete Phase IV post-approval studies to confirm that the product confers benefits upon survival or other "irreversible morbidity". This raises an interesting possibility--since statistically significant ICP reduction occurred in a sample of just 67, it is probable that one would not need 800-1000 Phase III patients to show ICP benefits in a Phase III. One could potentially think of doing a smaller (300 pt study with ICP as the primary endpoint), in order to submit the NDA and obtain approval on that basis, with the condition that a large Phase IV (which could not be placebo-controlled, and thus becomes more difficult) be done later. I do not think this is likely, regardless of the regulations, I expect a survival or GOS type measure of functional outcome to be a primary endpoint in PhIII...but it does add an interesting twist to the possibilities.