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Samsa

04/28/17 6:58 AM

#26497 RE: zoomlik #26496

Zoo....There are too many moving parts to be able to tell. with the new FDA regulations that went into place December 6th, The FDA could continue with the application and make a quasi judicial decision as long as IPCI submits the 250 word supporting document. OR IPCI lawyers could file an Injunction stopping the FDA stay which in effect would allow the FDA to move forward while the case continues.

The latter is my best guess. IPCI could easily get an Injunction as they could argue that Purdue can not be harmed if the application is allowed to continue because the most they can hope for is Tentative approval anyway without a partner. How can Purdue say they can be damaged if IPCI can not sell the drug? so IPCI can just request an Injunction saying there will be no harm to Purdue if the application is allowed to continue because they cant obtain a final approval.