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Biotech / Medical : CYPB - Cypress BioScience -- Ignore unavailable to you. Want to Upgrade?

To: John S. Baker who wrote (240)	5/28/1998 3:31:00 AM
From: Jay Lowe	Read Replies (1) \| Respond to of 586

John ... what this means is a major change in the procedure Cypress can use in filing the information for FDA approval of the RA indication of the Prosorba product. What's going on is as follows: - Prosorba was been in use for some time to treat ITP, a bleeding disorder. - Prosorba was tested successfully to be of major benefit in rheumatoid arthritis (RA) - the test above was ended early because the results were so clear (that's the bit about the Phase III Trial ending early) - to bring Prosorba to market for use in RA treatment, CYPB has to file a PMA - this is called "filing a PMA" for the RA indication of Prosorba - Filing a PMA is a huge paperwork task, much more intricate than a patent filing - the PMA process consists of various stages - the FDA has "fast-tracked" the PMA process - the effect is that Cypress can now file each stage's documents as they go - so they don't have to wait until all the stages are complete to begin Effect on Stock - before this news, CYPB's next major milestone was the PMA filing schedule for Jul/Aug - the "fast-tracking" means the process can begin now - before this news, there was not much reason so expect stock price increase prior to Jul/Aug - now, there is reason to suppose that the stock price may begin to move sooner - increased probability of completing a successful filing (FDA is unlikely to fast-track something they might disapprove, eh?) Target Stock Price - CYPB closed today at 2.938 - analyst price targets for the stock range from $6.75 - $10.00 (12 month)