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Posted On: 07/03/2022 1:49:16 PM
Post# of 148892
At least 2 PRs Tuesday,
1) Cyrus as President to become CEO
I was too lazy to transcribe what Tanya was saying about Cyrus. The PR will probably sound a lot like what she said.
2) NIH grant
I like your thinking:
1) Clinical hold lifted
Seems like they are thinking September for the clinical hold to be lifted.
2) BLA submission happens after clinical hold is lifted as per what has been bolded. So let's give that November .
3) Yes, we will get $ from Amarex.
I have felt this will come to a resolution in December 2022 or January-February 2023 .
comes from here:
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
4) on the NASH front:
can happen any time really, but I would say after Amarex is done makes the imminency of this ever more likely, but still can happen without Amarex over and done with. The BLA and lifting of the hold doesn't have to do with this. Let's give this October .
taken from:
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
Yes, bringing Cyrus on was a very important step to begin our transition into CytoDynasty.
So order of events:
September: Lifting of the Clinical Holds
October: 1st Partnership revealed
November: BLA submission
December 2022 -February 2023: Amarex comes to a close.
January 2023: Cyrus inaugurated as CEO
1) Cyrus as President to become CEO
I was too lazy to transcribe what Tanya was saying about Cyrus. The PR will probably sound a lot like what she said.
2) NIH grant
Quote:
Now, as Antonio mentioned, we do have some exciting news to announce regarding an NIH grant for HIV cure. We will be announcing this shortly, but OSHU has received ~$5 million grant from NIH to evaluate the role of LRM in HIV cure.
I like your thinking:
1) Clinical hold lifted
Quote:
18:05 Scott Kelly: Thank you Antonio. So, I would like to begin by addressing the partial clinical hold on our HIV program & clinical hold on our Covid 19 program. To provide project management timelines for submitting the necessary materials in September of this year. Our initial time frame of 8-12 weeks, was dependent on us being provided data from former CRO according to industry standards. In the process of analyzing the data, in conjunction with our pharmacovigilance experts, we realized we needed to convert the data into industry standard format. To be clear, We have the data. It is really a data conversion issue. Unforeseen data quality and other data related issues remain a risk that could impact the time line. AM, do you want to add some color on this?
18:50 Antonio Migliarese: Thanks Scott. One of the things we want to highlight is that addressing the clinical hold is our number one priority in the organization and this is an all hands on deck effort. As we mentioned earlier, we have a strong project team in place, which is led internally, by our chief top performers, who have vast industry experience including an internal project manager. This is led by our senior director of clinical operations, Joe Meidling and our vp of project management, Bernie Cunningham. We've additionally engaged in CRO, clinical research organization that has deep experience in root sources in the areas of pharmacovigilance, safety data based management analysis. We also have the regulatory consulting firm that is assisting us with the preparation and review of the various regulatory communication, and lastly we have the data to work with an overall regulatory strategy advising group. This group is one of the most reputable at being regulatory consulting firms led by former FDA regulators. To provide a little more color on our project management, this team has a line by line detailed project plan with paths, timelines and milestones where its various team members are accountable. Our team holds a series of meetings designed to check in, discuss, progress for milestones, roadblocks and risks to the critical paths. These meetings occurs at various intervals throughout the week and the month. This allows us to identify issues as quickly as possible to trouble shoot and identify ways to overcome and impact on overall timeline. Furthermore, this allows us to identify opportunities to bring in additional resources and where if possible to expedite time.
Quote:
We are working diligently to lift the clinical holds by providing the necessary materials to the FDA, and have requested a type c meeting.
Quote:
We are currently working to achieve the deliverables required by the FDA to lift the clinical hold. We have requested a type c meeting with the FDA to gain further guidance with respect to completion of the BLA. Once we achieve the lift on clinical hold and receive further clarities from our type c meeting request from the FDA, we will be in better position to provide an updated timeline analysis .
Seems like they are thinking September for the clinical hold to be lifted.
2) BLA submission happens after clinical hold is lifted as per what has been bolded. So let's give that November .
3) Yes, we will get $ from Amarex.
I have felt this will come to a resolution in December 2022 or January-February 2023 .
Quote:
I feel justice will come to Amarex and all those parties involved. I do not believe Amarex will come out of this arbitration intact by any means whatsoever. I believe that with CytoDyn's successful victory in the Amarex arbitration, CytoDyn will be lifted up greatly and will give rise to a level of respect from the Big Pharma community which it wasn't expecting. CytoDyn will be acknowledged that it was wronged and partners will do what they can to ensure a successful new BLA submission. It will prove to be a new beginning for CytoDyn with the amicable support of Big Pharma to work together with CytoDyn in collaborative partnerships to bring necessary modalites for these difficult indications. Amarex almost completed their dirty work and almost CytoDyn with their dasterdly deed, but in the end, it will be that exact endeavor to sabotage the BLA which induces their bomb to backfire and be detonated upon their own head and not CytoDyn's.
comes from here:
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
4) on the NASH front:
can happen any time really, but I would say after Amarex is done makes the imminency of this ever more likely, but still can happen without Amarex over and done with. The BLA and lifting of the hold doesn't have to do with this. Let's give this October .
Quote:
Where are we? We are at the beginning. We are standing on the brink of a new day. When will the first partnership be signed? NASH has good results. Good enough for BTD IMO. mTNBC has good results. LRM could easily be combined with a PD inhibitor for both NASH and mTNBC giving it a double indication with one partner. That combo drug could be given BTD swiftly and succeed in Phase 3 trials. A good PD inhibitor in combo with LRM could dominate these 2 markets for years to come.
When this partnership is established, the industry will be turned on it's head. Two monoclonal antibodies, one targeting PD inhibition and the other immunomodulating CCR5. Tremendous trial outcomes result and blockbuster status in the making. One deal like this is all CytoDyn needs, but CytoDyn will have many like this. And these deals will be long lasting too. Many deals, on many fronts. That's what LRM specializes in...
taken from:
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
Yes, bringing Cyrus on was a very important step to begin our transition into CytoDynasty.
So order of events:
September: Lifting of the Clinical Holds
October: 1st Partnership revealed
November: BLA submission
December 2022 -February 2023: Amarex comes to a close.
January 2023: Cyrus inaugurated as CEO
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