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"Manufacturing readiness" -- why did today's PR include a seemingly superfluous reference to such a possible use for the new funding? A friendly suggestion -- if you are among the many board members who are disinterested in "timelines to approvals," "anything that hasn't happened" yet, or "bread crumbs," stop reading and return to the topic index to find something that will interest you.
If you're still reading, consider yourself forewarned -- everything beyond this point is highly speculative and tethered only to my long ago experience in handling negotiations that involved significant sums of money, but which were peanuts compared to drug company BO money.
As I've previously stated in prior posts, leverage is a precious commodity in any negotiation. However, a corollary to that principle is that if you are perceived as attempting to overplay your leverage, you lose credibility in the eyes of your opponents. Therefore, if you're going to bluff while attempting to utilize your leverage, it better be a credible bluff.
CYDY is obviously aware that any potential acquirer or partner would be tracking its PRs. The funding announcement was characterized as a noteworthy accomplishment of critical importance to insuring CYDY's ability to continue conducting essential clinical trials into 2027. No other explanation for the use of the funds was required -- but a seemingly superfluous sentence then mentioned the possibility of using some of the funding for "manufacturing readiness."
Earlier today, some posters suggested that the manufacturing reference was a tell that BO/partnerships must be caput and that CYDY is planning to go it alone. Maybe so -- if CYDY has received, and expects to receive, only scant interest to acquire Leronlimab, but Dr Jay has publicly stated that CYDY does not expect to commercialize LL. And, if multiple drug companies are still pursuing at least reasonably serious negotiations with CYDY, pending the release of CRC clinical trial data, they would presumably realize that the reference to "manufacturing readiness" was not intended as a threat to go it alone, since CYDY doing so would not be viewed as credible, whether intended as a bluff or otherwise.
So, in what context would spending precious funding on "manufacturing readiness" be a credible predicate to gain any leverage in a price negotiation? I submit the most likely answer would be the plausibility of an FDA approval of LL in the relatively near future -- say the first half of 2027. Otherwise, the gratuitous declaration by CYDY to possibly use precious 2026 funding on "manufacturing readiness" would make utterly no sense as a bargaining ploy unless both sides comprehended that LL approval is actually a possibility well before late 2028 or beyond, -- as would be consistent with FDA historical approval timelines.
But, if CYDY can negotiate a BO or partnership in the next 6 to 9 months, why would the timing of an LL approval be of any consequence? Because, I would submit, the perception by both sides that an approval is reasonably possible/probable in 2027, as opposed to years later, would mean revenue from the deal much sooner and, therefore, substantially better terms for CYDY (and many more patient lives saved by LL).
Whether the above scenario has any chance of playing out will likely depend on whether the FDA continues to move the approval goal posts closer. There have been definite signs of movement in that direction, but the future is always uncertain.
Stay tuned.
If you're still reading, consider yourself forewarned -- everything beyond this point is highly speculative and tethered only to my long ago experience in handling negotiations that involved significant sums of money, but which were peanuts compared to drug company BO money.
As I've previously stated in prior posts, leverage is a precious commodity in any negotiation. However, a corollary to that principle is that if you are perceived as attempting to overplay your leverage, you lose credibility in the eyes of your opponents. Therefore, if you're going to bluff while attempting to utilize your leverage, it better be a credible bluff.
CYDY is obviously aware that any potential acquirer or partner would be tracking its PRs. The funding announcement was characterized as a noteworthy accomplishment of critical importance to insuring CYDY's ability to continue conducting essential clinical trials into 2027. No other explanation for the use of the funds was required -- but a seemingly superfluous sentence then mentioned the possibility of using some of the funding for "manufacturing readiness."
Earlier today, some posters suggested that the manufacturing reference was a tell that BO/partnerships must be caput and that CYDY is planning to go it alone. Maybe so -- if CYDY has received, and expects to receive, only scant interest to acquire Leronlimab, but Dr Jay has publicly stated that CYDY does not expect to commercialize LL. And, if multiple drug companies are still pursuing at least reasonably serious negotiations with CYDY, pending the release of CRC clinical trial data, they would presumably realize that the reference to "manufacturing readiness" was not intended as a threat to go it alone, since CYDY doing so would not be viewed as credible, whether intended as a bluff or otherwise.
So, in what context would spending precious funding on "manufacturing readiness" be a credible predicate to gain any leverage in a price negotiation? I submit the most likely answer would be the plausibility of an FDA approval of LL in the relatively near future -- say the first half of 2027. Otherwise, the gratuitous declaration by CYDY to possibly use precious 2026 funding on "manufacturing readiness" would make utterly no sense as a bargaining ploy unless both sides comprehended that LL approval is actually a possibility well before late 2028 or beyond, -- as would be consistent with FDA historical approval timelines.
But, if CYDY can negotiate a BO or partnership in the next 6 to 9 months, why would the timing of an LL approval be of any consequence? Because, I would submit, the perception by both sides that an approval is reasonably possible/probable in 2027, as opposed to years later, would mean revenue from the deal much sooner and, therefore, substantially better terms for CYDY (and many more patient lives saved by LL).
Whether the above scenario has any chance of playing out will likely depend on whether the FDA continues to move the approval goal posts closer. There have been definite signs of movement in that direction, but the future is always uncertain.
Stay tuned.
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