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kayak_wench

09/25/23 9:25 PM

#388354 RE: WeeZuhl #388352

The CC from end of June noted that they filed a partial application in the spring to get the PDUFA date going in the spring.

That CC also explained they had previously filed.

We disclosed a while back that we're actually continued working on a generic version of Oxycodone. And the last time we filed it, we had deficiencies and one of the deficiencies that everybody got is that an insufflation study was not conducted. It was cost prohibitive. That study alone is about $1.5 million, $2 million, and this is why we put the project on hold.



So Elite has been telling us for months they had filed again and why....do you listen to CCs anymore?