Quote:If that's correct (and please correct me if I'm wrong), did the drug ever receive approval for that indication or do you have to have a successful Biologics License Application in order to obtain a drug approval from the FDA?
And is there any thought to using a good CRO to refile the BLA, or has the market moved away to another solution for treatment-experienced patients?
An approval is based on a BLA. Our BLA was bounced three times by the FDA because the idiots at Amarex kept filing a BLA that was incorrectly structured and had missing data. When Cytodyn sued to get the data they found severe deficiencies. The only way to fix it would be to gather the data at each trial location and that was from two different trials one of which was ongoing for years. When HIV treatment was daily with side effects then leronlimab made sense as a solution. Shortly after our last filing there was a combo drug approved that was monthly with minimal side effects so we were left in the dust. The market for leronlimab would have been very small and it would not have been worth the time and expense to pursue it.
On the bright side I invested because of the initial BLA filing. If that hadn't occurred I would have never discovered what else leronlimab was capable of.
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