z: Thank you for your thoughts on your expectation
Post# of 155159
(Total Views: 584)
Posted On: 07/20/2023 2:07:41 PM
z: Thank you for your thoughts on your expectations for the CC. You opine that CYDY will announce that it has provided the requested info to the FDA. I hope you are correct, but note that Form 423(b)3, which is dated July 11, specifically indicates that CYDY is still preparing that submission.
You also opine that the "FDA is not looking to approve (LL) for the (HIV) MDR population. In this prediction, history regarding CYDY/LL and the FDA is clearly, and perhaps persuasively, is on your side. But I find interesting, in a troubling sense, your additional analysis that the FDA's request for submission of a full HIV clinical trial protocol may simply relate to the FDA's curiosity regarding " a go forward path for LL in HIV" in terms of "what are you guys trying to accomplish in HIV."
Given the devastation that the HIV safety related hold has wreaked upon CYDY's market cap. share price, ability to raise funds needed to remain in business, and ability to launch clinical trials with or without partners, the possibility that the FDA has continued to extend this hold for several months beyond when CYDY has submitted all of the requested safety related data simply in order to satisfy the idle curiosity of FDA staffers regarding a benefit risk analysis of LL for HIV and the content of a draft HIV protocol that may or may not ever be formally submitted, is deeply concerning. And even more concerning if CYDY's bare boned staff has spent the last few months, and perhaps several more into the future, drafting the requested benefit risk analysis ( which would make more sense in the context of consideration of drug approval than drug safety) and drafting such an involved, complex document as a clinical trial protocol. If this is where we are at, God help us. But, as I said above, history and the odds support your conclusion that accelerated approval is not in the cards.
You also opine that the "FDA is not looking to approve (LL) for the (HIV) MDR population. In this prediction, history regarding CYDY/LL and the FDA is clearly, and perhaps persuasively, is on your side. But I find interesting, in a troubling sense, your additional analysis that the FDA's request for submission of a full HIV clinical trial protocol may simply relate to the FDA's curiosity regarding " a go forward path for LL in HIV" in terms of "what are you guys trying to accomplish in HIV."
Given the devastation that the HIV safety related hold has wreaked upon CYDY's market cap. share price, ability to raise funds needed to remain in business, and ability to launch clinical trials with or without partners, the possibility that the FDA has continued to extend this hold for several months beyond when CYDY has submitted all of the requested safety related data simply in order to satisfy the idle curiosity of FDA staffers regarding a benefit risk analysis of LL for HIV and the content of a draft HIV protocol that may or may not ever be formally submitted, is deeply concerning. And even more concerning if CYDY's bare boned staff has spent the last few months, and perhaps several more into the future, drafting the requested benefit risk analysis ( which would make more sense in the context of consideration of drug approval than drug safety) and drafting such an involved, complex document as a clinical trial protocol. If this is where we are at, God help us. But, as I said above, history and the odds support your conclusion that accelerated approval is not in the cards.
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