Silicon Investor (SI) -- The First Internet Community

STOCKTALK

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 : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?

To: Jim Roof who wrote (825)	4/2/1998 1:05:00 PM
From: Stephen How	Respond to of 1432

I don't think Hextend can exceed the hetastarch limit of 1.5 liters/day (20ml/kg/day). Do you mean that it CAN not or that it MAY not? The conference in Puerto Rico confirmed that up to 5 liters were tolerated by patients. Who is it who says that there is a limit? Does the FDA make such a limit? Physicians? Jim, I think that a drug is accompanied by indications for safe use. I also think that the NDA must specify a maximum dosage. For example, an NDA for some aspirin-type drug may have to include it's maximum indicated dosage. If this aspirin-type drug is then approved for 1500mg/day, a doctor may not be insulated from malpractice if he prescribes 5000mg/day, if the practice isn't widely accepted. Sure, I can see how a doctor can safely prescribe a drug for untested beneficial (at least benign) effects. I think the key is safety. I'm sure Hextend or hetastarch can be used in larger-than-indicated dosages quite frequently. I'm sure this is actually common in many procedures already, before the advent of Hextend. (We went over all this before ... Note the double-blind protocol probably treated the Phase III hetastarch patients with 2-5 l also ...) Again, let's just check with Biotime if a maximum indicated dosage was filed in the NDA. Steve