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dtstx

08/27/15 11:49 AM

#12967 RE: mopar44o #12960

Even if you knew the number, how would that help you? Sprot couldn't get Domenic, awhile back, to acknowledge any CRL's on any ANDA, to confirm there was communication going on. The mere fact Domenic stated they're looking at least 1 approval this year tells us they cleared the NDA hurdle and are working on getting that 1 ANDA in order to comply with the FDA.

How many amendments will the company have to submit? How much communication will have to take place back and forth before the FDA is satisfied? Each of those could take several months. So it is impossible to nail any time as each ANDA may require different requirements and that's without getting into the competence and consistency of the FDA reviewer.

We have only 3 working days left this month and not a single 1 of those 329 ANDA's I laid out 11 days ago has been approved. They have their 10 "first time generics" done once again as previous months. That means a whooping 78% of the approvals so far this month have been with ANDA's submitted after our 3 oldest.

Those other 329 are in flux, caught up by the FDA requirement changes made after they were submitted. It sucks but that's why we're fighting to get through the quagmire.