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illmatix0711

05/09/17 4:06 AM

#26862 RE: fabius #26861

bonjour,

i dont think you can affect an approval this way.

im not a lawyer but imagine how you could impact the market with such easy manipulation tools ...

i think it s an intern problem, also because it has been online already.

i contacted ir again maybe they talked to the fda or sth ...

greetz
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Samsa

05/09/17 6:20 AM

#26867 RE: fabius #26861

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?