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Re: The ELTP King post# 385842

Wednesday, 08/23/2023 10:22:15 AM

Wednesday, August 23, 2023 10:22:15 AM

Post# of 403243
We can learn the outcome of the BE study before the CC if they submit the ANDA for a needle mover before the CC. If the BE was good, we know they plan to release the ANDA before end of calendar year, we also have Nasrat on record saying "We always issue press releases when we submit an ANDA with the FDA." in the last CC. He never said anything about issuing a press release in that CC for the BE results. In fact, him not saying that in the same CC that he noted he would get results and expected those results to be good speaks volume.

In the same CC just before he noted that Elite always PRs ANDA submissions he even noted
"We've done quite a few BE and insufflation and pilot studies this year. One, we will get the results for tomorrow, and I expect it to be positive and it's one of the needle movers."

Do you think they failed all of those studies!? Its just more likely they have decided to no longer PR BE studies than they failed every one they had done this year.
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