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Posted On: 07/14/2023 10:35:35 PM
Post# of 154227
FORM 424B3:
We have had 26 clinical studie previously conducted and Leronlimab was generally well-tolerated...in addition,...there were No dose-limiting Toxicities or patterns of drug-related Toxicities observed during these trials.
We believe the results of theses trials established that Leronlimab's Antiviral activity is Potent...Rapid...and Prolonged dose dependent and Statistically significant.
In short...We have the DATA...and it was adjudicated by the third party consultants...that were former ex-FDA reviewers.
All the studies that are listed on clinicaltrials.gov website that concern Leronlimab have been updated without retractions or major concerns. The DATA appears to be fine.
It is generally believed on other channels... that we can move forward with a BLA submission for HIV MDR...only caveat... We must get the hold lifted.
We have had 26 clinical studie previously conducted and Leronlimab was generally well-tolerated...in addition,...there were No dose-limiting Toxicities or patterns of drug-related Toxicities observed during these trials.
We believe the results of theses trials established that Leronlimab's Antiviral activity is Potent...Rapid...and Prolonged dose dependent and Statistically significant.
In short...We have the DATA...and it was adjudicated by the third party consultants...that were former ex-FDA reviewers.
All the studies that are listed on clinicaltrials.gov website that concern Leronlimab have been updated without retractions or major concerns. The DATA appears to be fine.
It is generally believed on other channels... that we can move forward with a BLA submission for HIV MDR...only caveat... We must get the hold lifted.
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