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Replies to #81116 on Biotech Values
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stockbettor

07/20/09 7:34 PM

#81121 RE: DewDiligence #81116

The key distinction between the two cases is that the DDSS application is an NDA while the NVS/MNTA application is an ANDA. As you probably know, ANDA’s do not have prescribed timelines.

Thanks, I see from a November 2008 press release that DDSS had a 7/18/09 PDUFA date, which the FDA obviously satisfied.
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DewDiligence

07/20/09 7:37 PM

#81123 RE: DewDiligence #81116

Minor correction to #msg-39720275:

“As you probably know, ANDA’s do not have prescribed timelines.”

Make that proscribed, not prescribed :- )