ohm: Your view of the scope of the clinical hold m
Post# of 155506
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Posted On: 09/29/2022 12:48:05 PM
ohm: Your view of the scope of the clinical hold may well be spot on, but it does not track with a reasonable interpretation of the March 30 PR announcing it. The inference you have drawn that the FDA has informed CYDY that no new trial protocol will be evaluated until the hold is lifted may well be accurate, but the PR specifically references only HIV and covid. If your view is correct, it only heightens my concern because that would mean that the FDA, which both of us agree would only approve LL based on overwhelming data demonstrating efficacy and safety, has positioned itself to preclude future LL trials indefinitely as it requires CYDY to weave through several widely spaced meetings to discuss the ongoing course of the Brazilian covid/heart patients and the whereabouts/status of miscoded Amarex safety data. With the FDA as the exclusive arbiter of whether CYDY can conduct future trials in Nash and/or cancer, it cannot be assumed that CYDY will ever conduct any trial during the sale period for the 350 million new shares. Accordingly, that dire possibility suggests to me the need to seriously consider any reasonable buyout options that may arise.
I fully concur with your position that any buyout offer should be evaluated for reasonableness based on an assessment of projected drug revenues over the ensuing 5 years. With an unapproved drug like LL, such an evaluation becomes an educated guess to a considerable degree. I would submit, however, that the floor for a "reasonable" bid just got lower. Any future Nash or cancer trial is several months away from commencing, at best, and may not ever happen under CYDY management (see above paragraph). Moreover, we learned from the call that the continued survival of the cancer trial patients is meaningless for FDA purposes. And management's ability to leverage its utilization of the 350 million shares through a catalyst driven rise in the sp appears very problematic over the foreseeable future.
While not ignoring that LL is likely that best drug ever developed, and, as such, has tremendous revenue potential, the fact remains that even under the current more focused management, eventual FDA approval cannot be assumed. Therefore, it strikes me that what may have been deemed an unreasonably low bid 6 months or a year ago, may currently qualify as reasonable. And that's my guess as to why Cyrus took the buyout question and responded by emphasizing management's fiduciary duty relative to any pending or future offer.
As always, I greatly appreciate your response to my post and your several other posts this morning in the wake of the CC. During my years on the board, your explanations and insights have consistently established you as our most valuable and irreplaceable poster. Many thanks.
I fully concur with your position that any buyout offer should be evaluated for reasonableness based on an assessment of projected drug revenues over the ensuing 5 years. With an unapproved drug like LL, such an evaluation becomes an educated guess to a considerable degree. I would submit, however, that the floor for a "reasonable" bid just got lower. Any future Nash or cancer trial is several months away from commencing, at best, and may not ever happen under CYDY management (see above paragraph). Moreover, we learned from the call that the continued survival of the cancer trial patients is meaningless for FDA purposes. And management's ability to leverage its utilization of the 350 million shares through a catalyst driven rise in the sp appears very problematic over the foreseeable future.
While not ignoring that LL is likely that best drug ever developed, and, as such, has tremendous revenue potential, the fact remains that even under the current more focused management, eventual FDA approval cannot be assumed. Therefore, it strikes me that what may have been deemed an unreasonably low bid 6 months or a year ago, may currently qualify as reasonable. And that's my guess as to why Cyrus took the buyout question and responded by emphasizing management's fiduciary duty relative to any pending or future offer.
As always, I greatly appreciate your response to my post and your several other posts this morning in the wake of the CC. During my years on the board, your explanations and insights have consistently established you as our most valuable and irreplaceable poster. Many thanks.
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