a lot of this comes in response to Scott Kelly's comments in last conference call on 3/31/22:
and
Quote:We are in communication with ANVISA and the FDA and reported the events to each agency, but this was CytoDyn's decision. Full clinical hold on US IND Covid 19, and partial clinical hold for IND for HIV. The FDA wants aggregated safety data across all indications as our prior CRO was not aggregating safety data. We will correct this. We believe this is a solvable problem. We have contracted with a new pharmaco-vigilance CRO to move forward. So we expect about an 8-12 week, (June-July 2022), timeline and seek advice from the FDA.
and
Quote:We are also processing 3 articles for publication in peer reviewed journals.
1st) in on HIV monotherapy. : https://d1io3yog0oux5.cloudfront.net/_13142be...pecies.pdf
2) HIV multidrug resistance.
3) Covid 19 Long Haulers program. :
https://d1io3yog0oux5.cloudfront.net/_13142be...iac226.pdf
Potential Partnerships: regarding A) NAFLD; looking both internationally and domestically;
for 1) HIV Prep, we hope to use long acting LL, pending results of macaque study currently being done for once every 3 months injection,
looking for partners in 2) Multidrug resistant HIV,
3) partners to complete the BLA submission with Inhouse BLA expertise,
we are looking at partnerships in 4) HIV combo both internationally and domestically;
partnerships with 5) existing agents that LL would be a great add on agent. and also with
6) HIV and
7) NASH looking to do a phase 2 clinical trial for obvious reasons.
For HIV patients, they have increased risk of NAFLD and NASH compared to general population.
Looking at combo therapy for NASH with LL and existing agent.
Market is growing at 58.64% annually. Expected to be $180.9billion by 2028.
In oncology, we are pursuing partnerships in unmet medical needs and quicker paths to approval. We do know that CCR5 is present on many tumors that are unmet medical needs as well as the tumor micro environment.
Cancer immunotherapy is projected to be $277 billion by 2030 growing by 12.6%.
Focus is on Partnerships for immunotherapy combination.
Migliarese 20:35: Amarex audit is wrapping up. Amarex arbitration slated for mid-April 2022.
Kelly 22:22, so we are in discussions, we have companies under NDA right now .
we are advancing the discussions for multiple different applications for LL. But we will have to comment on that when it is publicly available to everybody at the same time.
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