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Replies to #60665 on Biotech Values
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exwannabe

03/25/08 10:26 PM

#60666 RE: junta #60665

Re FLML Coreg dates

The OP was about the flame out in 2007, so these dates certainly seam reasonable.

But I will disagree with Dew and go with the majority opinion that Coreg-CR can not sell against the generic Coreg-IR at a fraction of the price.

Did FLML (or the patent holder) file suit against the challanger? If not, the the generic -CR will be on market in less than a year.

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DewDiligence

03/25/08 11:25 PM

#60668 RE: junta #60665

>FLML – oops almost missed the dates
11/19/2007
12/21/2007
not exactly timely info, right?<


Actually, it is timely.

The FDA disclosed the Paragraph-IV challenge for Coreg CR this week. The dates cited above were when the ANDA’s for the two doses of Coreg CR were submitted.

The FDA keeps the existence of a Paragraph-IV challenge confidential until the ANDA in question is accepted for filing purposes.