SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Pharmos (PARS) -- Ignore unavailable to you. Want to Upgrade?


To: NeuroInvestment who wrote (975)1/25/2000 6:56:00 PM
From: Rick Strange  Respond to of 1386
 
Thanks for the feedback. One wonders sometimes if the FDA is the gateway or the roadblock to quality healthcare when it comes to our drug and medical device supply. Logic too often seems to be bogged down by their dogged "non passerent" (THEY SHALL NOT PASS) attitude. Sometimes it is necessary to take limited but yet controllable risk to achieve an objective, especially when there are no alternatives.

I think they have milked the Thalidamide story (how many decades old) for about as far as it will go and should start taking a proactive course toward reducing the inane cost and time to bring new lifesaving medical developments to market.

Maybe it is time that Congress started conducting oversight hearings to find out why the FDA has ignored, or at best, paid only lip service to some FDA reform legislation passed years ago. I'll step down off of my soap box now.

Thanks again.



To: NeuroInvestment who wrote (975)1/26/2000 7:19:00 AM
From: Gabe Fernandez  Read Replies (1) | Respond to of 1386
 
CONFUSED: What is the primary purpose of the study?. From a medical point of view if you lower ICP without affecting mean systemic blood pressure you automatically increase cerebral perfusion. In my mind the whole purpose is to improve cerebral perfusion + aiding in the prevention or reduction of the patho-physiological changes that occur following cerebral trauma. Please educate me if wrong.



To: NeuroInvestment who wrote (975)4/13/2000 12:36:00 PM
From: Ron  Read Replies (1) | Respond to of 1386
 
Dr. Tracy,
I know in your post #975 you wrote that the FDA has made it clear to Pharmos that they will not allow ICP to be the primary endpoint in phase 3 for HU-211.

My question is why wouldn't the FDA allow ICP as an endpoint if the drug improves the condition of TBI victims by lowering ICP without lowering the blood pressure. I believe I have read somewhere that lowering the ICP could prevent the devastation caused by the "cascade" effect.

Thank you.