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Friday, July 01, 2022 10:08:11 AM
Nasrat didn't go into detail about what we can expect/hope for in terms of progress in the next 6 months. In the Q3 call he noted "For 2022, we have two products under review by FDA, both are licensed products co-developed with partners. We expect approval for one during the first half of 2022."
The antibiotic was not one of them.
Q1: So based on typical review times can we 'expect' another approval in the next 6 months?
I also didn't get a clear picture of whether they are going to file any ANDAs this year much less the 4 he has noted in earlier calls. Every time he talks about them he talks about delays in clinical trials problems getting excipient etc.
He did say "We have six ANDAs that are -- at R&D level that are well-developed and we have a total of 12 that range from early development all the way to clinical trials."
Does that mean the 6 ANDAs that 'well-developed' are not waiting on clinical trials? I don't think so because in Q3 call I thought he was saying clinical trials was impacting the goal of 4 ANDAs filed.
Bottom line I left that call not knowing whether we would get 1 ANDA filed this year much less 4.
Q2: Does anyone have any insight to provide on whether we can expect any ANDAs to be filed this year?
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