The FDA HIV BLA response letter from January 2020
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Posted On: 06/11/2025 3:17:30 AM
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The FDA HIV BLA response letter from January 2020 said that data was missing. It would have been available from the test sites. Either Amarex didn't bother collecting it or just didn't put it in the BLA. It wouldn't surprise me if that happened with subsequent trials.
To your point, Ohm, just yesterday the clinicaltrials.gov site had a new revision on the "Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC" trial (ClinicalTrials.gov ID NCT03838367).
Over three years after the last patient was dosed, CYDY has finally found the data, presumably from the test sites, and come up with the results. Which I'm looking forward to seeing -- more msTNBC data. Unfortunately, it's again with the three dose levels. But it is bound to be an improvement over Carboplatin alone (which is not an arm in the study, but known all the same).
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