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Posted On: 12/09/2022 8:20:32 AM
Post# of 148870
docj says:
"CYDY has swung and missed time after time."
Some thoughts about the past and the future that came to mind after reading docj's post.
Over the years I've been invested in CYDY, there have been numerous times I commented on what seemed to be Nader's buckshot strategy. I think it was the best he could do, and probably made a lot of sense to him. He wanted to get a bunch of disease states started in as small and cheap a way as possible, so that he could prove there was value in many different indications. This would land us a larger buyout, or, and I think this is something he believed, the initial data would be so compelling that the FDA would surely help rush this medication to market in these very important indications. I mean, why wouldn't the government want to step in and help bring LL to market for Covid when people are dying left and right and early data showed it was safe and effective?
(Spoiler alert: Maybe they would have been more willing to help if Amarex wasn't doing such a shit job)
If you remember way back to a call during early covid, Jay Lalezari spoke about how Cytodyn went to the FDA right away when the first few patients recovered in Seethamraju's clinic. Then after the next couple, and again and again as a few more patients and a few more patients got better. I think they went to them four or five times in fairly quick succession, with no success. To me, that's the approach Nader was relying on. Early but compelling data, and the FDA would surely fast track us in every way possible. In a perfect world, that's how it should work.
That sort of thing happened a lot. Studies with just enough patients to eek out a result, not preparing for possible issues with randomization or study design. Wanting to possibly stop studies early if they could show some results at interim analysis. Compiling and submitting results for mTNBC breakthrough designation before they even had the ability to calculate a proper mean overall survival number. Submitting 12+ months, instead of waiting to be able to say what that number was definitively. Or at bare minimum, keep officially tracking those patients so you could follow up with the right number. That one in particular turned out to bite us in the ass almost immediately, when we were less capable of showing just how much better we'd be than the "new" gold standard.
There are so many examples where better decisions would have likely resulted in better results. And I understand that money isn't endless or sometimes thinks just don't go your way. I think Nader had an approach that was somehow both too careful and too risky at the same time. He also had unrealistic expectations about the FDA, and how they would respond to small but compelling data. He never learned from his pie-eyed approach and subsequent failures or setbacks.
Cyrus, on the other hand, is far more aware of what it takes to bring a drug to market. I see him building a better, stronger team. A better, stronger game plan for gaining approvals. A better, stronger case for being invested in CYDY.
A couple things got me thinking about how that looks moving forward. The first is KenChowder wondering about Amarex and this update to the bond collateral. The second is this snippet (pulled from a stocktwits post) from Cyrus that apparently came on the call (which I logged off of very early) explaining the basic approach moving forward:
"However, because this is all going to be funding dependent, we're going to focus on Nash initially, and work with co-development partners to the extent we can to develop in oncology."
So...
It looks like Cytodyn is preparing to be done with the need for a bond by the end of January. They're giving back $1.5 million in cash collateral now, and set a deadline for the remainder to be returned by January 31st. If the bond is no longer needed, the arbitration must be over, no?
If the arbitration is over, Cytodyn could be looking at tens of millions of dollars coming back into the ol' checking account. Maybe as much as $80 million.
That news would surely bump the share price upward. Getting the hold lifted would/should too. There are plenty of shares to offer, and should the share price rise to 2-3x the current price those dollars all of a sudden go a lot further. Even with a longer, more expensive phase 3 trial(s) it wouldn't be unthinkable that there would be enough money around soon to get those started without a partner.
(Spoiler alert: I feel like they should partner for Nash)
Concerning what Cyrus said (and I'm assuming this quote was pulled properly from the call I didn't listen to) I read that as "we're starting with Nash because we don't have deep pockets. Cancer is next, and because we don't have deep pockets that program will be dependent on what kind of co-development deals we can make."
Meaning, we can start one expensive indication, but that's about all we can afford. Starting a secondary indication will require partners. I'm not going to lie, it really sounds like Cyrus is preparing to start Nash up without help. Maybe a partner comes along at some point during phase 3, or maybe not. But those words aren't like any number of hard to decipher sentences we'd get out of Nader on calls or in PR's. This seems pretty clear to me.
And having the cash to start a phase 3 Nash trial has to come from somewhere, which is why the arbitration/bond filing is so interesting.
For what it's worth, assuming that I'm correct, I'm not in favor of it unless there are literally no partners willing to step up with a reasonable deal. We'll get to approvals faster and with more success if we get the help of a well-connected, big pharma partner. It also wouldn't mean we have to keep flying so close to the sun with funding issues. It would be great to feel like we're going to be stable financially for a while.
Did anyone hear any comments about Nash partners during the call, which again, I didn't listen to? Anything that contradicts that one line? Because otherwise it looks like Cyrus is getting ready to go after Nash alone.
"CYDY has swung and missed time after time."
Some thoughts about the past and the future that came to mind after reading docj's post.
Over the years I've been invested in CYDY, there have been numerous times I commented on what seemed to be Nader's buckshot strategy. I think it was the best he could do, and probably made a lot of sense to him. He wanted to get a bunch of disease states started in as small and cheap a way as possible, so that he could prove there was value in many different indications. This would land us a larger buyout, or, and I think this is something he believed, the initial data would be so compelling that the FDA would surely help rush this medication to market in these very important indications. I mean, why wouldn't the government want to step in and help bring LL to market for Covid when people are dying left and right and early data showed it was safe and effective?
(Spoiler alert: Maybe they would have been more willing to help if Amarex wasn't doing such a shit job)
If you remember way back to a call during early covid, Jay Lalezari spoke about how Cytodyn went to the FDA right away when the first few patients recovered in Seethamraju's clinic. Then after the next couple, and again and again as a few more patients and a few more patients got better. I think they went to them four or five times in fairly quick succession, with no success. To me, that's the approach Nader was relying on. Early but compelling data, and the FDA would surely fast track us in every way possible. In a perfect world, that's how it should work.
That sort of thing happened a lot. Studies with just enough patients to eek out a result, not preparing for possible issues with randomization or study design. Wanting to possibly stop studies early if they could show some results at interim analysis. Compiling and submitting results for mTNBC breakthrough designation before they even had the ability to calculate a proper mean overall survival number. Submitting 12+ months, instead of waiting to be able to say what that number was definitively. Or at bare minimum, keep officially tracking those patients so you could follow up with the right number. That one in particular turned out to bite us in the ass almost immediately, when we were less capable of showing just how much better we'd be than the "new" gold standard.
There are so many examples where better decisions would have likely resulted in better results. And I understand that money isn't endless or sometimes thinks just don't go your way. I think Nader had an approach that was somehow both too careful and too risky at the same time. He also had unrealistic expectations about the FDA, and how they would respond to small but compelling data. He never learned from his pie-eyed approach and subsequent failures or setbacks.
Cyrus, on the other hand, is far more aware of what it takes to bring a drug to market. I see him building a better, stronger team. A better, stronger game plan for gaining approvals. A better, stronger case for being invested in CYDY.
A couple things got me thinking about how that looks moving forward. The first is KenChowder wondering about Amarex and this update to the bond collateral. The second is this snippet (pulled from a stocktwits post) from Cyrus that apparently came on the call (which I logged off of very early) explaining the basic approach moving forward:
"However, because this is all going to be funding dependent, we're going to focus on Nash initially, and work with co-development partners to the extent we can to develop in oncology."
So...
It looks like Cytodyn is preparing to be done with the need for a bond by the end of January. They're giving back $1.5 million in cash collateral now, and set a deadline for the remainder to be returned by January 31st. If the bond is no longer needed, the arbitration must be over, no?
If the arbitration is over, Cytodyn could be looking at tens of millions of dollars coming back into the ol' checking account. Maybe as much as $80 million.
That news would surely bump the share price upward. Getting the hold lifted would/should too. There are plenty of shares to offer, and should the share price rise to 2-3x the current price those dollars all of a sudden go a lot further. Even with a longer, more expensive phase 3 trial(s) it wouldn't be unthinkable that there would be enough money around soon to get those started without a partner.
(Spoiler alert: I feel like they should partner for Nash)
Concerning what Cyrus said (and I'm assuming this quote was pulled properly from the call I didn't listen to) I read that as "we're starting with Nash because we don't have deep pockets. Cancer is next, and because we don't have deep pockets that program will be dependent on what kind of co-development deals we can make."
Meaning, we can start one expensive indication, but that's about all we can afford. Starting a secondary indication will require partners. I'm not going to lie, it really sounds like Cyrus is preparing to start Nash up without help. Maybe a partner comes along at some point during phase 3, or maybe not. But those words aren't like any number of hard to decipher sentences we'd get out of Nader on calls or in PR's. This seems pretty clear to me.
And having the cash to start a phase 3 Nash trial has to come from somewhere, which is why the arbitration/bond filing is so interesting.
For what it's worth, assuming that I'm correct, I'm not in favor of it unless there are literally no partners willing to step up with a reasonable deal. We'll get to approvals faster and with more success if we get the help of a well-connected, big pharma partner. It also wouldn't mean we have to keep flying so close to the sun with funding issues. It would be great to feel like we're going to be stable financially for a while.
Did anyone hear any comments about Nash partners during the call, which again, I didn't listen to? Anything that contradicts that one line? Because otherwise it looks like Cyrus is getting ready to go after Nash alone.
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