ohm: I can assure you, with the utmost regret, that the sentence you quoted was written in total good faith. The possibility (some might even suggest likelihood) that the FDA, due to the influence of some element of BP, will never approve LL for any indication has increased significantly in my mind over the last 18 months or so. The FDA's insistence on a severe/critical covid trial protocol that an elementary school nurse would have realized was doomed to fail, and its hatchet job on CYDY in its aftermath bely reasonable explanation. The FDA's reliance on heart problems in patients in a foreign based covid trial not even subject to its jurisdiction as the basis (per your analysis) to place a hold (for 6 months and counting) on all future LL clinical trials is utterly irrational, especially in light of the FDA approving BP drugs that are clearly ineffective and cause serious side effects in some patients. I could go on with other head scratching examples, but the 2 above are more than sufficient for me to become concerned that this FDA will never approve LL under CYDY management. And if there is even a reasonable possibility that this hypothesis is accurate, the discounted 5 year value of LL revenue is impacted significantly. Or more explicitly, if the FDA intends to block LL from approval while in CYDY's hands, the company will be unable to raise money well before 5 years have elapsed.
As previously indicated, all of the above is only my opinion (or guess if you prefer). I have no inside knowledge at either end of the CYDY/FDA equation, I may be wrong and sincerely hope that I am. Be that as it may, I do not share your confidence that some combination of CYDY or third party initiated lawsuits, bureaucratic aversion to negative media publicity, or bureaucratic fear of in house discipline will insure ultimate fair treatment of LL under CYDY ownership.
Any lawsuit against the United States challenging FDA decision making would be incredibly costly, incredibly time consuming, and exceedingly difficult to win, especially in the District of Columbia US District Court. Moreover, from what I have watched on the news in recent years, federal agencies and their employees are not in the least deterred from engaging in indefensible conduct by negative media coverage, especially since only a handful of outlets would even cover any criticism of the current administration. And with regard to bureaucrats fearing unfavorable reviews by supervisors, it is almost impossible to fire anyone working for the governments and even demotions are exceedingly rare.
The hypothesis I have set out does not require some complicated conspiracy to be true, and I think that is unlikely here. Rather, I suspect it simply requires the active intervention of one or more FDA employees or supervisors who have become subject to the influence, for whatever reason, of one or more BP companies who have approved or clinical stage drugs that would compete with LL for sales revenue. The existence of such a situation, if it were in play, would be consistent with the FDA's track record of irrational conduct regarding LL.
So, in the utmost good faith, I remain concerned.
As previously indicated, all of the above is only my opinion (or guess if you prefer). I have no inside knowledge at either end of the CYDY/FDA equation, I may be wrong and sincerely hope that I am. Be that as it may, I do not share your confidence that some combination of CYDY or third party initiated lawsuits, bureaucratic aversion to negative media publicity, or bureaucratic fear of in house discipline will insure ultimate fair treatment of LL under CYDY ownership.
Any lawsuit against the United States challenging FDA decision making would be incredibly costly, incredibly time consuming, and exceedingly difficult to win, especially in the District of Columbia US District Court. Moreover, from what I have watched on the news in recent years, federal agencies and their employees are not in the least deterred from engaging in indefensible conduct by negative media coverage, especially since only a handful of outlets would even cover any criticism of the current administration. And with regard to bureaucrats fearing unfavorable reviews by supervisors, it is almost impossible to fire anyone working for the governments and even demotions are exceedingly rare.
The hypothesis I have set out does not require some complicated conspiracy to be true, and I think that is unlikely here. Rather, I suspect it simply requires the active intervention of one or more FDA employees or supervisors who have become subject to the influence, for whatever reason, of one or more BP companies who have approved or clinical stage drugs that would compete with LL for sales revenue. The existence of such a situation, if it were in play, would be consistent with the FDA's track record of irrational conduct regarding LL.
So, in the utmost good faith, I remain concerned.
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