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 : SCIO Scios Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (1340)	4/19/2001 5:32:02 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 1477

Does anybody else draw the same negative inference? I don't, but this person knows quite a bit more about BT than me. >>Natrecor (an IV drug for acute congestive heart failure)-is going before an FDA panel meeting on May 25 (see recent newsletter in the Biotech Insight archives-for subscribers only). This cannot be good news for Scios. The best possible scenario would have been no panel meeting -just an FDA approval. Scios already had a panel meeting and the drug was recommended for approval but the FDA declined the recommendation making the company do a further study to evaluate Natrecor head to head with the standard of care-IV nitroglycerin (NTG)-this study will be reviewed by the new panel. On my reading the new study showed no increase in hypotensive episodes with Natrecor as compared to NTG. This is what the FDA was really interested in. Furthermore, Natrecor looked a little better than NTG at 3 hours using pulmonary wedge pressures as an end point. Patients also felt less short of breath on Natrecor compared to NTG. In my mind the FDA shouldn't need another panel meeting unless there are other considerations-and this could definitely be a negative. My bet is that Natrecor will get approved-the side effect profile (headache) appears better than that of NTG and this could be enough even if all other things are equal. However the downside risk is substantial-if Natrecor is not approved the stock tanks-so that is the gamble-are you feeling lucky?<< biospace.com Wilder