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Posted On: 05/19/2021 8:58:32 AM
Post# of 148908
From The Mobile Desk of VacationRespert24
Location: Secret
5/19/2021
8:01am
As many as four of you may have been wondering where I've been. Wondering whether or not I have anything to say about the FDA going out of their way to shit on CYDY, during trading hours no less. Maybe even wondering whether the beef shortage caused by the coronavirus has led to dangerously low iron levels in your hero, leaving me too weak to post regularly.
Res(per)t assured that my steak consumption is at an all time high, including a ribeye topped with a bacon relish just last night. A bottle of J Lohr Pure Paso followed by a bottle of Jordan Cabernet washed it down. I wasn't alone, so don't call an intervention just yet. And if need be I'll switch to hippo. Seriously. Google "meat shortage hippo" for an interesting read on the subject.
And I have been trying to keep up with the fireworks even though the "show" has basically felt we bought the world's best fireworks kit and later found out it was just a box with a couple sacks of flour taped inside for weight.
But like those stories you occasionally hear about where a man decides to put a new frame on the weird painting he found at a garage sale for $1 and finds a Renoir underneath, those bags of white powder actually contain a substance far more explosive than big fireworks wants you to believe. That raw, uncut LL is going to rattle the world.
Like many of you, I watched a fairly massive amount of money disappear from my spreadsheet. This happened right after I did two things, in case you want to feel like it isn't just you getting jabbed in the eye with a hot poker.
First, my upstairs HVAC bit the dust. Along with the new system, we're redoing the shoddy ductwork upstairs as well as the ductwork on our other system downstairs. Rerouting, adding returns, widening vents. The whole shebang. This crappy news was preceded by my decision to take the family on a little trip. Nothing crazy, just a couple nights a short drive away, but between the two I quickly ended up down 15k before the FDA letter even came out. So it's been twice as annoying for me the last few days. The only lucky moment was when I sold a small bit of my holdings to help fund these two projects at $2.74, right before the drop. Then again, if I was truly lucky this would have happened back when it was bouncing around $6.
Like many of you I'm frustrated with the FDA. What kind of asshole authorizes that in the first place without paying attention to facts? And what kind of supreme asshole then decides to release it DURING trading hours? I hope some savvy investor is able to out whoever it was that penned it and/or chose to release it the way they did. There deserves to be some public shaming of that person or team. Which coincidentally is probably why the did it in the first place. Lots of people calling them out on their bullshit.
But does the letter change anything?
I don't think any sane investor thought we were realistically going to get an EUA here in the states without more data. Which means many other countries likely won't or wouldn't budge without more data. It sucks, because by all accounts we should be the perfect choice for an EUA, but you can't teach an old dog new tricks and the FDA isn't going to change their glacially paced, archaic process for little old Cytodyn. They'll get the data they need and it'll be fine. That's what Brazil is for. That's what a proper trial design will provide. There'll be irrefutable proof that the FDA can finally except. At which point the mood will switch from the entitled asshole looking down at LL into the smiling and inviting host, who immediately pulls out all the stops because they realize they've stumbled upon a whale. Right this way, Mr. Papagiorgio. Your penthouse suite is ready.
As sure as I'll continue to eat two filets whenever I'm on the road for work, Leronlimab will continue to prove itself in trials, EINDs, OLEs, CSPs, cancer, Longhaulers, HIV, GVD, and probably 64 other acronym-heavy conditions from Ohm20's list. The science is strong and the future is bright. Nobody ever said it would be easy.
Lastly, here's a good post from "Money Made Money Kept" on the yahoo board:
I've been wanting to add my perspective as a long-time regulatory professional after seeing the statement from FDA yesterday, hearing doom and gloom summaries of the CC from various naysayers, and then listening to the CC myself. TL
R summary = I thought the call went very well given the circumstances, and things still seem to be on track.
First and foremost I was impressed with the unified, conciliatory and friendly tone of CYDY management towards FDA, which must have been a challenging position to take after the events of yesterday. This means they are clearly focused on moving forward with US FDA, and that they are not willing to indulge in conspiracy theories of BP/FDA corruption and other distractions which (whether true or not) are just that - distractions. If Nader and CYDY management ever decide to start indulging such distractions and stop focusing on making forward progress, I will promptly sell all of my shares.
The tone and content of the FDA statement from yesterday was consistent with many I have read before in confidential correspondence with them. The only reason I can think that it was published on FDA's website is that they must have been facing overwhelming public advocacy for Leronlimab, and clearly some of it (probably a lot of it) was from people who are misinformed. Some of this can be fairly blamed on the hyperbole of CYDY executive management, which I've unfortunately found to be ubiquitous among small biotech C-suites; however, some blame must also go to FDA, who has made a number of high-profile blunders and questionable approvals throughout this pandemic. Regardless, over the years I have regularly had to reassure stakeholders that FDA is simply incredibly risk-averse, and their written correspondence should not be taken personally. It is unfortunate that their statement was made publicly available to shareholders at large, who have clearly over-reacted given that no new information was shared with us.
Finally, the clarity Nader provided on their move overseas makes perfect sense in the context of drug development: if you live in a country where there are no patients in your intended treatment population (i.e. severe COVID), you must go overseas to enroll patients. It had nothing to do with FDA asserting that there was no path forward for Leronlimab. This was a straightforward and sensible answer to my main question of what precipitated the move overseas, and whether it had to do with bad blood here in the US.
In sum: I'm not surprised by the FDA letter, although I feel its publication was unfair to CYDY shareholders. However, life is often unfair, and companies must not be distracted by fairness if they are to succeed (the same is true for investors). CYDY seems focused on keeping their heads down and generating the data that is needed to move forward, and contrary to what STAT news keeps insisting, the totality of available data supports the conclusion that CCR5 is an important therapeutic target in multiple indications. I can't guarantee that CYDY will succeed against the many headwinds that small biotech companies face, nor am I thrilled about the slow pace of progress and occasional setbacks, but I continue to hold my shares because I don't feel that the thesis has changed. An approval of some type (EUA, BLA, etc) still seems likely for CYDY in the near future.
Location: Secret
5/19/2021
8:01am
As many as four of you may have been wondering where I've been. Wondering whether or not I have anything to say about the FDA going out of their way to shit on CYDY, during trading hours no less. Maybe even wondering whether the beef shortage caused by the coronavirus has led to dangerously low iron levels in your hero, leaving me too weak to post regularly.
Res(per)t assured that my steak consumption is at an all time high, including a ribeye topped with a bacon relish just last night. A bottle of J Lohr Pure Paso followed by a bottle of Jordan Cabernet washed it down. I wasn't alone, so don't call an intervention just yet. And if need be I'll switch to hippo. Seriously. Google "meat shortage hippo" for an interesting read on the subject.
And I have been trying to keep up with the fireworks even though the "show" has basically felt we bought the world's best fireworks kit and later found out it was just a box with a couple sacks of flour taped inside for weight.
But like those stories you occasionally hear about where a man decides to put a new frame on the weird painting he found at a garage sale for $1 and finds a Renoir underneath, those bags of white powder actually contain a substance far more explosive than big fireworks wants you to believe. That raw, uncut LL is going to rattle the world.
Like many of you, I watched a fairly massive amount of money disappear from my spreadsheet. This happened right after I did two things, in case you want to feel like it isn't just you getting jabbed in the eye with a hot poker.
First, my upstairs HVAC bit the dust. Along with the new system, we're redoing the shoddy ductwork upstairs as well as the ductwork on our other system downstairs. Rerouting, adding returns, widening vents. The whole shebang. This crappy news was preceded by my decision to take the family on a little trip. Nothing crazy, just a couple nights a short drive away, but between the two I quickly ended up down 15k before the FDA letter even came out. So it's been twice as annoying for me the last few days. The only lucky moment was when I sold a small bit of my holdings to help fund these two projects at $2.74, right before the drop. Then again, if I was truly lucky this would have happened back when it was bouncing around $6.
Like many of you I'm frustrated with the FDA. What kind of asshole authorizes that in the first place without paying attention to facts? And what kind of supreme asshole then decides to release it DURING trading hours? I hope some savvy investor is able to out whoever it was that penned it and/or chose to release it the way they did. There deserves to be some public shaming of that person or team. Which coincidentally is probably why the did it in the first place. Lots of people calling them out on their bullshit.
But does the letter change anything?
I don't think any sane investor thought we were realistically going to get an EUA here in the states without more data. Which means many other countries likely won't or wouldn't budge without more data. It sucks, because by all accounts we should be the perfect choice for an EUA, but you can't teach an old dog new tricks and the FDA isn't going to change their glacially paced, archaic process for little old Cytodyn. They'll get the data they need and it'll be fine. That's what Brazil is for. That's what a proper trial design will provide. There'll be irrefutable proof that the FDA can finally except. At which point the mood will switch from the entitled asshole looking down at LL into the smiling and inviting host, who immediately pulls out all the stops because they realize they've stumbled upon a whale. Right this way, Mr. Papagiorgio. Your penthouse suite is ready.
As sure as I'll continue to eat two filets whenever I'm on the road for work, Leronlimab will continue to prove itself in trials, EINDs, OLEs, CSPs, cancer, Longhaulers, HIV, GVD, and probably 64 other acronym-heavy conditions from Ohm20's list. The science is strong and the future is bright. Nobody ever said it would be easy.
Lastly, here's a good post from "Money Made Money Kept" on the yahoo board:
I've been wanting to add my perspective as a long-time regulatory professional after seeing the statement from FDA yesterday, hearing doom and gloom summaries of the CC from various naysayers, and then listening to the CC myself. TL
R summary = I thought the call went very well given the circumstances, and things still seem to be on track. First and foremost I was impressed with the unified, conciliatory and friendly tone of CYDY management towards FDA, which must have been a challenging position to take after the events of yesterday. This means they are clearly focused on moving forward with US FDA, and that they are not willing to indulge in conspiracy theories of BP/FDA corruption and other distractions which (whether true or not) are just that - distractions. If Nader and CYDY management ever decide to start indulging such distractions and stop focusing on making forward progress, I will promptly sell all of my shares.
The tone and content of the FDA statement from yesterday was consistent with many I have read before in confidential correspondence with them. The only reason I can think that it was published on FDA's website is that they must have been facing overwhelming public advocacy for Leronlimab, and clearly some of it (probably a lot of it) was from people who are misinformed. Some of this can be fairly blamed on the hyperbole of CYDY executive management, which I've unfortunately found to be ubiquitous among small biotech C-suites; however, some blame must also go to FDA, who has made a number of high-profile blunders and questionable approvals throughout this pandemic. Regardless, over the years I have regularly had to reassure stakeholders that FDA is simply incredibly risk-averse, and their written correspondence should not be taken personally. It is unfortunate that their statement was made publicly available to shareholders at large, who have clearly over-reacted given that no new information was shared with us.
Finally, the clarity Nader provided on their move overseas makes perfect sense in the context of drug development: if you live in a country where there are no patients in your intended treatment population (i.e. severe COVID), you must go overseas to enroll patients. It had nothing to do with FDA asserting that there was no path forward for Leronlimab. This was a straightforward and sensible answer to my main question of what precipitated the move overseas, and whether it had to do with bad blood here in the US.
In sum: I'm not surprised by the FDA letter, although I feel its publication was unfair to CYDY shareholders. However, life is often unfair, and companies must not be distracted by fairness if they are to succeed (the same is true for investors). CYDY seems focused on keeping their heads down and generating the data that is needed to move forward, and contrary to what STAT news keeps insisting, the totality of available data supports the conclusion that CCR5 is an important therapeutic target in multiple indications. I can't guarantee that CYDY will succeed against the many headwinds that small biotech companies face, nor am I thrilled about the slow pace of progress and occasional setbacks, but I continue to hold my shares because I don't feel that the thesis has changed. An approval of some type (EUA, BLA, etc) still seems likely for CYDY in the near future.
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