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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (4380)7/31/2001 9:57:42 AM
From: rkrw  Read Replies (2) | Respond to of 52153
 
<<It looks to me to be clearly better than straight Ritalin - a longer duration of action if nothing else, and hopefully easier titration of dosage.>>

An issue is that the celg version will be going up against JNJ's extended release ritalin. The celg nda filed drug is not once-per-day. This could limit it's market potential. I'm not sure when the celg extended release isomer version will be nda filed.



To: Biomaven who wrote (4380)8/3/2001 1:56:38 PM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
CELG - ritalin:

The NDA was filed at the very end of 2000, with an overly optimistic "It is expected that the review will be completed in the third quarter of 2001."

A correction here - this was the date the FDA accepted the application not the application date - the actual PDUFA target date is actually later this month.

My apologies for the error.

Peter


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