Replies to post #59167 on Biotech Values

[zipjet]

>>The main significance of a decision upholding the lower court will be that the 180-day H-W exclusivity clock finally starts ticking.

I understand.

Does that make any difference to the FDA? Might they get on with approval BECAUSE the drug can get to market?

IF those questions are answered in the affirmative then there may be some upside to affirming the trial court.

Otherwise - we remain at the whim of the FDA. And who knows when they will act.

ij

[ghmm]

The main significance of a decision upholding the lower court will be that the 180-day H-W exclusivity clock finally starts ticking.

I have heard Momenta say this on a couple of occasions. If they don't receive FDA approval though, challenge when the 180 day exclusivity begins or is that pretty cut-and-dry? I remember hearing Craig Wheeler saying another avenue would be to try and have the 180-day waiting period waived if a competitors FDA approval is futile. Another possibility was negotiating with whomever would get the 180-day.