Fabius.....This would not surprise me one bit! the Generic competition is fierce. If indeed filing a Citizens Petition stalls the granting of final approvals which the law at least suggests it can. I have yet to find the exact regulation which states it must. then absolutely a company could use this to their advantage.
Its no different than what we are seeing with the Purdue litigation to stall the NDA. companies know they can get up to a 30 month stay merely by filing. In this case. why did a person wait until half way through the exclusivity period to question the legitimacy about the exclusivity?
Now, what I haven't figured out is if I am correct, why didn't they at least get approval on the single dose Par didn't have?