All Aboard
Another week closer. All of us on a ride. We are all on a train and in a week or so we get the news.
For some, the news becomes a crash. For others, the news means the ride keeps going & it picks up speed from there.
Shorts singing songs, jovial and elated, even drinking their fill, while longs bite their finger nails.
The next PR comes and the short train derails and hits a wall, while PR allows the long train to continue forward while accelerating. That's the power of the next PR. It either crashes the short train or allows the long train to continue along in acceleration and it all depends upon the seat position on the train.
Destination is either train wreck or buy out / partnership / clinical trial.
Shorts, yeah, this question goes to the Shorts. Who put you on the train? Who told you to buy a ticket?
Longs, we know why you're on. You've looked at the molecule and were sold.
I think we know where this is going. I think we have been reading the puzzle pieces correctly. I think it jives with what CytoDyn has been telling us. I think it jives with leronlimab's capacity as a safe treatment for HIV.
"The Company recently provided additional information to the FDA that we believe answers the FDA’s remaining questions. We hope this submission will lead to the removal of the clinical hold*. The Company is on standby to address any other issues that may be noted by the FDA, and is optimistic that the time, effort and significant cost investment over the past year* will result in the removal of the hold*.*"
"We anticipate Dr. Lalezari working with us for the next few months while the Company resolves the clinical hold and makes key decisions as it relates to getting back into clinical trials and evaluating strategic partnerships*. With his industry relationships and knowledge, we believe Dr. Lalezari is uniquely suited to keep the Company’s clinical strategy and* potential partnership initiatives moving*.”*
Dr. Lalezari stated, “I am eager to help CytoDyn move forward its corporate objectives. Indeed, I agreed to serve as interim CEO due to my belief in leronlimab and its potential. I have worked with leronlimab (and previously PRO 140) for almost 20 years, and I am pleased to step in during this critical juncture in which the Company seeks to come off clinical hold, get back to conducting trials and develop a drug that helps patients. I believe the Company can make significant and immediate progress on a number of key objectives*.*"
Everything CytoDyn has been saying is that the Lifting/Removing of the clinical Hold is Coming. If I look further, I'm sure I can find more instances.
What CytoDyn mentioned in the July 24,23 Webcast is that they would hire a CEO. In addition, they said they had just completed the KOL meeting. In the Shareholder Letter, they discussed the items of hiring a CEO, they discussed the KOL meeting and they discussed a Manufacturing Technology Transfer. We know that the KOL meeting was done. We know the "final" submission was made by the Shareholder letter dated 11/3/23. We know Dr. Jacob Lalezari was hired as CEO on 11/17/23. We also have proof of the Manufacturing Technology Transfer in today's 8K. What is left? The FDA must result by 30 days of 11/3/23, if there are no questions and we haven't heard of any. CytoDyn said they would be doing a better job of communicating and so far, nothing. So far, so good, no questions then.
Technology Transfer Statement: 11/3/23 Shareholder Letter
"Throughout our history, CytoDyn has made great strides in developing leronlimab from a single indication molecule into a platform molecule with the potential for multiple therapeutic indications. Through CytoDyn’s investment in clinical trials, we have generated valuable data demonstrating how leronlimab might be used in HIV, oncology, metabolic dysfunction-associated steatohepatitis (“MASH” formerly “NASH”), and metabolic dysfunction-associated steatotic liver disease (“MASLD”). We have also successfully transferred our manufacturing technology allowing us to manufacture leronlimab at scale in preparation for clinical trials and potential FDA approval."
Manufacturing Technology Transfer Proof: 11/28/23 8K
"On November 21, 2023, Samsung BioLogics Co., Ltd. (“Samsung”), informed CytoDyn Inc., a Delaware corporation (the “Company”), of Samsung’s intent to terminate, effective January 5, 2024, the Master Services Agreement (the “Agreement”) entered into between Samsung and the Company in April 2019. The Agreement provides for Samsung to perform non-exclusive services relating to technology transfer, process validation, manufacturing, pre-approval inspection, vial filling, and supply and storage services for leronlimab bulk drug substance and drug product. Samsung paused manufacturing for all unfulfilled commitments under the Agreement in January 2022. The Company currently holds sufficient leronlimab to conduct its prospective clinical trial(s) in the short term, and will also be continuing its efforts to resolve outstanding issues under the Agreement with Samsung, including the contractual requirements for notice of breach and termination, an extended payment schedule to address any outstanding past due balance, and the continued postponement of manufacturing."
Shorts still can't get over the fact that Dr. Jacob Lalezari has been hired as CEO. They just can't admit it. Something CytoDyn said would happen, actually happened. They cannot bring such things to their lips. If they had a say on whether the KOL meeting would have happened, 10:1, they would have denied that, but it was done behind closed doors so their short naysaying would not interfere with the outcome. What do you think shorts think will happen regarding FDA result? Of course we know the answer to that. Their only answer is to say the hold will not be lifted. Can shorts believe that a monoclonal antibody manufacturer would want to do business with CytoDyn, a company who owes millions to Samsung? Certainly not! They would never in a million years believe that this manufacturer would want a stake in CytoDyn or would want to partner or buy out CytoDyn. Yet, the Technology Transfer occurred. Samsung has cancelled with CytoDyn. But everything CytoDyn has said in this regard so far has happened and everything that had to happen in preparation for the hold to be lifted has happened. The KOL meeting, the submission and now the CEO hiring & manufacturing technology transfer. Only thing left is the FDA result and to learn who CytoDyn's new manufacturer/partner is.
In fact, their only prediction for CytoDyn's future is Reverse Split. Yet, it makes zero sense to issue more shares if this is CytoDyn's plan. But, RS is the only solution that works into their understanding which tells you they have no understanding. They refuse to contemplate any other solution, only, bankruptcy. This is how they stay on the short train. Keep pushing the RS and they can ride the short train. Essentially, they sell the company short in their understanding. Essentially, they are saying that everything the company has been saying is garbage. That everything the company has put out in webcasts, letters, and press releases is garbage. Rather, people should listen to them who know better.
They know, that if they reference company words, then they will have to consider that what the company has said has come about. They would have to admit that there is a possibility that the FDA does remove the hold and if that is a possibility, then there is a possibility for the share price to rise, etc... They don't want any of these possibilities. They want everyone on the short train.
Here I am, and not just me, but many a long hollering over to the shorts, "Better get off the short train mister". I think, if you don't get off the short train, you might be soon fall frightened, freak out and faint with fear. Don't say I didn't warn you. My central words of warning, making them relevant to the shorts. Train wreck incoming.
Guess what shorts, Long's ain't selling. We ain't getting on your train. We're staying put, right we are, cause this coming together and adding up. The pieces are painting a buy out or a partnership is in the works. In the words of MLAB, "But, I’ll keep it short. We are getting bought out! Plain and simple!"
All of this took place while we were twiddling our thumbs, while the bashers were bashing, while CytoDyn could care less about share price. They knew what was happening behind the scenes. The manufacturing technology was being transferred to a partner. No word from Samsung. This was not even discussed in the 12/7/22 R & D Update, yet, the Update pointed to CytoDyn's future. CytoDyn is coming home. The quietness of the past year which we passed on explains the future where we are headed, Partnership or Buy Out.
Get off the train shorts. Your choice. You'll see, dear old mazzy will get you right back on. No, no, no, stay seated where you are, you're fine, you don't want to get off, there is nothing else to see with CytoDyn, we are just waiting for RS and bankruptcy. MGK knows shit.
MGK looks at the signs. Shorts are headed for a train wreck.
Posted Nov 28, 2023, 11:57 PM UTC