About the company's completed Phase 3 trial with l
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Posted On: 11/05/2024 8:25:16 PM
About the company's completed Phase 3 trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients (which happened before I bought in), my understanding is that it met its primary endpoint but was unsuccessful in filing its BLA.
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?
Or is there another reason we aren't pursuing that indication when we've already had a successful trial? Maybe it has something to do with the recent macaque rhesus experiments? I did not invest in the company until after the Phase 3 HIV trial, so I don't know this part of the history that well and am thanking you in advance for any enlightenment.
Thanks, Ramjet
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?
Or is there another reason we aren't pursuing that indication when we've already had a successful trial? Maybe it has something to do with the recent macaque rhesus experiments? I did not invest in the company until after the Phase 3 HIV trial, so I don't know this part of the history that well and am thanking you in advance for any enlightenment.
Thanks, Ramjet
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