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Posted On: 04/10/2023 6:03:51 PM
Post# of 153915
Interesting passage in the 10Q. Probably gives an idea of what to expect tomorrow as far as the clinical work relatively near term:
The Company’s efforts are currently primarily directed toward obtaining the removal of the partial clinical hold on its HIV program, preparation for and development of a Phase 2b/3 NASH clinical trial protocol, research and development of longer-acting molecules including for the treatment and/or prevention of HIV, maintenance and testing of clinical drug product, and resolving legal and regulatory matters.
No mention of cancer, and nothing specific on it in the 10Q other than details of the TNBC data. So the focus definitely seems to be on one trial, NASH, which was mentioned as a possibility in the Dec science presentation but this makes it seem more set in stone. I really like a focus on a long-acting HIV treatment. If leronlimab can effectively become a cure...go with what nobody else has. Also the first mention I've seen of Nash being specifically a Phase 2b/3. We'll see if Cyrus says pivotal tomorrow. I expect that he will.
Also more details on the hold:
As of the date of this filing, the Company has submitted the following to the FDA in connection with resolving the clinical hold: an aggregate analysis of cardiovascular events across all leronlimab clinical programs, a Safety Surveillance Plan, an aggregate safety data analysis, an updated Investigator’s Brochure, annual reports, a benefit-risk assessment, and a general investigational plan. The Company is currently working on a supplemental submission to address items discussed with the FDA during a late March 2023 informal meeting.
The Company’s efforts are currently primarily directed toward obtaining the removal of the partial clinical hold on its HIV program, preparation for and development of a Phase 2b/3 NASH clinical trial protocol, research and development of longer-acting molecules including for the treatment and/or prevention of HIV, maintenance and testing of clinical drug product, and resolving legal and regulatory matters.
No mention of cancer, and nothing specific on it in the 10Q other than details of the TNBC data. So the focus definitely seems to be on one trial, NASH, which was mentioned as a possibility in the Dec science presentation but this makes it seem more set in stone. I really like a focus on a long-acting HIV treatment. If leronlimab can effectively become a cure...go with what nobody else has. Also the first mention I've seen of Nash being specifically a Phase 2b/3. We'll see if Cyrus says pivotal tomorrow. I expect that he will.
Also more details on the hold:
As of the date of this filing, the Company has submitted the following to the FDA in connection with resolving the clinical hold: an aggregate analysis of cardiovascular events across all leronlimab clinical programs, a Safety Surveillance Plan, an aggregate safety data analysis, an updated Investigator’s Brochure, annual reports, a benefit-risk assessment, and a general investigational plan. The Company is currently working on a supplemental submission to address items discussed with the FDA during a late March 2023 informal meeting.
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