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  4. CytoDyn Inc (CYDY) Message Board

Angry: I, too, have a measure of optimism based on

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Post# of 153767
(Total Views: 590)
Posted On: 07/25/2023 4:03:53 PM
Posted By: Jake2212
Re: AngryMan #136127
Angry: I, too, have a measure of optimism based on the same language from the transcript that you highlighted. After the Form 424(b)3 was issued by CYDY on July 11, I posted regarding the inferences that I drew from pages 24-25; namely, that the language suggested accelerated approval of LL to treat the HIV MDR patient population and a follow up confirmatory clinical trial might be under consideration. However, subsequent interpretations of the same language by other board members suggesting a meaning consistent with further FDA delaying tactics were certainly supported by CYDY/FDA history.

Accordingly, I was elated when management during the CC referenced the FDA's request "to obtain expert opinion and feedback from HIV patient advocates and Key Opinion Leaders regarding the HIV subpopulation they believe to benefit from LL." Although the words "accelerated approval" were never uttered during the CC (notwithstanding the many questions submitted by me and others regarding "accelerated approval", I cannot believe that the quoted CC language references anything else than accelerated approval being under consideration. And, as I observed in my original post regarding this subject, I would expect the FDA to listen to and heed HIV patient advocates regarding the efficacy and safety LL has demonstrated in treating HIV patients.

If accelerated approval is granted before year end, I believe it will have a huge positive impact on HIV patients and generate a substantial flow of revenue going forward for CYDY. Seeing the sp drop again today, I am amazed how few investors see what now seems plain enough to you and me.


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