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Posted On: 10/18/2024 8:40:06 AM
Post# of 148870
Consider this: Dr. Lataillade hiring;
Nov. 2023 Letter:
* Unfortunately, to date, we have been delayed in our efforts to satisfy the FDA with our clinical hold submission(s). We have embarked on a more comprehensive effort to resolve the FDA’s lingering questions. These efforts include the Company’s hosting of a number of advisory board meetings with key opinion leaders (KOLs). Adding to our delay was the unanticipated medical leave taken by our then President, Dr. Arman creating additional delays in our subsequent resubmission.
However, these unforeseen circumstances provided the time needed to help us gain new insights and understanding of leronlimab in the current HIV treatment environment. Further, we were able to receive and incorporate the perspectives of some of the top HIV KOLs worldwide as to how they believe leronlimab can play a significant role in helping HIV patients, notwithstanding other therapeutic options currently available to patients. As part of this process, the Company engaged various new clinical, regulatory, and medical consultants and advisors with relevant experience and expertise that we believe will continue to benefit the Company for years to come.
* Our efforts are focused on successfully completing the resolution of the FDA’s partial clinical hold – having recently made a submission that we hope will be successful – and strengthening our leadership team.
___
Nov. 3rd, 2023:
Above shareholder letter.
Nov. 21st, 2023:
Dr. Lalezari is Interim CEO
Oct. 8th, 2024:
Dr. Lataillade
The 2023 Letter also mentions indications outside of HIV.
Dr. Lataillade news:
Dr. Lataillade will lead the Company’s global research and development strategy and oversee end-to-end R&D activities to advance the Company’s clinical development pipeline.
Who better KOL to consult, than ViiV? Let alone their GSK/Pfizer connections.
Now we see Dr. Lataillade is also overseeing all R&D activities beyond HIV. Matching the broad reach of the 2023 Nov. letter.
Point being --- I think, thinking on everything has been backwards.
My bet is ViiV & very likely GSK/Pfz, has played a key role in getting Cytodyn turned around.
They have a long time-frame of having worked with Dr. J.
Dr. J is the deepest knowledge of LL & the patents.
But still have to ask --- why would a ViiV / GSK / Pfz even care to see Cytodyn survive??
Re-think before even 2023 events.
ViiV owns one of our LL-PLS mutant bNab's.
How long do you think our FcRn has been under development?
& we own the Mab-CCR5 patents.
My bet ----
ViiV / GSK / Pfz said ok, let's help format the data & lift the hold, while the FcRn data materializes.
Under the "agreement" with Cytodyn, if the FcRn data is hitting certain goals, then we proceed with a deeper relationship @ Cytodyn.
All done @ public arms length.
The way big corps like to do things.
____
Oct. 7th FcRn news.
Oct. 8th, Dr. Lataillade news.
1st mention is HIV.
With overseeing all R&D on the programs mentioned in the 2023 Letter.
Nov. 2023 Letter:
* Unfortunately, to date, we have been delayed in our efforts to satisfy the FDA with our clinical hold submission(s). We have embarked on a more comprehensive effort to resolve the FDA’s lingering questions. These efforts include the Company’s hosting of a number of advisory board meetings with key opinion leaders (KOLs). Adding to our delay was the unanticipated medical leave taken by our then President, Dr. Arman creating additional delays in our subsequent resubmission.
However, these unforeseen circumstances provided the time needed to help us gain new insights and understanding of leronlimab in the current HIV treatment environment. Further, we were able to receive and incorporate the perspectives of some of the top HIV KOLs worldwide as to how they believe leronlimab can play a significant role in helping HIV patients, notwithstanding other therapeutic options currently available to patients. As part of this process, the Company engaged various new clinical, regulatory, and medical consultants and advisors with relevant experience and expertise that we believe will continue to benefit the Company for years to come.
* Our efforts are focused on successfully completing the resolution of the FDA’s partial clinical hold – having recently made a submission that we hope will be successful – and strengthening our leadership team.
___
Nov. 3rd, 2023:
Above shareholder letter.
Nov. 21st, 2023:
Dr. Lalezari is Interim CEO
Oct. 8th, 2024:
Dr. Lataillade
The 2023 Letter also mentions indications outside of HIV.
Dr. Lataillade news:
Dr. Lataillade will lead the Company’s global research and development strategy and oversee end-to-end R&D activities to advance the Company’s clinical development pipeline.
Who better KOL to consult, than ViiV? Let alone their GSK/Pfizer connections.
Now we see Dr. Lataillade is also overseeing all R&D activities beyond HIV. Matching the broad reach of the 2023 Nov. letter.
Point being --- I think, thinking on everything has been backwards.
My bet is ViiV & very likely GSK/Pfz, has played a key role in getting Cytodyn turned around.
They have a long time-frame of having worked with Dr. J.
Dr. J is the deepest knowledge of LL & the patents.
But still have to ask --- why would a ViiV / GSK / Pfz even care to see Cytodyn survive??
Re-think before even 2023 events.
ViiV owns one of our LL-PLS mutant bNab's.
How long do you think our FcRn has been under development?
& we own the Mab-CCR5 patents.
My bet ----
ViiV / GSK / Pfz said ok, let's help format the data & lift the hold, while the FcRn data materializes.
Under the "agreement" with Cytodyn, if the FcRn data is hitting certain goals, then we proceed with a deeper relationship @ Cytodyn.
All done @ public arms length.
The way big corps like to do things.
____
Oct. 7th FcRn news.
Oct. 8th, Dr. Lataillade news.
1st mention is HIV.
With overseeing all R&D on the programs mentioned in the 2023 Letter.
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