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 : MGI Pharma MOGN New patents, anti cancer -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (1562)	4/14/2005 10:14:08 AM
From: Icebrg	Read Replies (1) \| Respond to of 1826

Saforis. What struck me as rather unconventional is the way the company is handling the Saforis NDA. In the PR they said: >MGI PHARMA plans to submit an NDA for Saforis oral suspension based on the successfully-completed phase 3 trial by the end of the third quarter of 2005. A second phase 3 trial of Saforis oral suspension is now expected to begin shortly after the NDA submission is complete. This trial is being planned to further expand the potential applications of the product. I mean, why do they initiate the third trial so soon? The normal procedure would be to wait for FDA's verdict on the NDA, before even contemplating another phase III trial. Either these trials are very inexpensive to run or the company has a very high level of confidence, that FDA will approve based on the results from just one trial. Erik