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Not post hoc. It was interim and preplanned. That's why you have DSMBs. If it was purely a safety read, you just unblind a medical monitor in the pharmacovigilence group.
Yep. That distinguished leronlimab from other immunomodulators - even dex. There was no way to know, though, until they got the lab results. A big bounce back or a large build up of sequester drug in the body could have done more harm than good. Their proposed MOA elevated the need for reliable safety and lab data right at the time it became apparent it wasn't all being made available to the FDA or even the sponsor. It was a bad situation in a time of heightened tension and fear. We'll get there. We would have gotten there sooner without the paranoid shorts.
The also had the ironic bad luck that the doctors who were pushing for them the most were part of the teams best able to keep patients alive. If you went back and compared survival rates for Covid at those hospitals vs the general population, you could probably correct for some of the "placebo" effect. It was likely skillful medical teams. That they were asking to add leronlimab to their arsenal is very telling
Remember, the survival percentage for leronlimab was always excellent. The problem was a lack of distinction from placebo. If it had been a low survival rate, then it would have been a desperate measure to avoid futility, but, then it would have been wrong to continue enrollment. that 75% cutoff data and longer follow up to give placebo patients more time to die, sadly, would have either pushed them over the edge to statistical significance or given them enough hypothesis generating information to go back to the FDA and add an arm to the study to prove their MOA was the reason for response
Exactly. So, increasing the event horizon was to try to either get a better primary because they were overpowered or better distinguish between active and placebo because even 2 doses were thought to be able to help the patient survive the storm long term better than placebo and they thought they had that rather than just something to help the patients keep breathing for another day while the medical team worked to keep the patient alive. Both were bullish conclusions and likely correct. Neither was a reason to short and tie the hands of a company that was relying on investors to help finance a potentially life saving treatment for Covid
If it was a lack of power to hit the curve, they would have recommended enrolling more patients. You can't increase statistical power by waiting longer for your event horizon. You'd push it out if you looked overpowered, not underpowered and wanted a better primary endpoint or if your placebo group was responding better than expected and you thought that would fall off over time compared to treatment group. They never had any hint of being underpowered and no one ever claimed that.
You'd need to go back and run the numbers with the patient data they had available at the time. Chances were that they were looking overpowered at day 28 and were still seeing a hint of response at day 42. The other option was that they hoped the longer timeframe would distinguish placebo from leronlimab better if they were getting better than expected placebo response. They weren't allowed to go with day 14 per the FDA, I believe. It wasn't a cabal and it wasn't shorty knowing something we didn't. It might get have helped given the course of the disease and the stratification issue.
Clinical sites are required to maintain their records until after the last filing for an intern indication or the IND is closed out. They must be made available to the sponsor, their delegates and regulatory authorities. They can be sent off site but are normally requested to be able to be available on site within 3 to 5 business days of a request. That is pretty typical boilerplate language for site contracts. Anyone who does clinical research is set up for that.
Aaron seems to have some info on legal stuff. I did see on Stocktwits that he had said in the private Facebook group that the 6 million raised was to take over the bond. He thought the issue with Amarex wouldn't be resolved until October and Cytodyn had agreed to cover it within 6 months. So, that should no longer be an issue. TBH, if the company had ended up filling bankruptcy, that's who I would have wanted to get the patents anyway
Look at the last 10q. The FDA is reviewing the CMC. That was fixed last year
I have a feeling they ended up getting themselves caught up in a bit of a catch-22 around May 2020. The FDA wasn't looking at the MOA of leronlimab as an immunomodulator. To them, it was an antiviral. When they wanted to use it for COVID, it made no sense to them. Plus, there were those conspiracy theories that Covid was made in a lab and had sequence for n common with HIV. When the experts explained that they thought it would help with cytokine storm, not as an antiviral, it became a MOA that had the potential to cause major side effects - even though they had years of exposure. That may have put a closer eye on side effects and the gaping hole in their submission. Then you get NP wanting to go full force because of cost and his experience with the drug and the FDA barely wanting to take baby steps to not make things worse. Add to that the craziness of a pandemic and a presidential election and everything that happens becomes very understandable. Now that things have calmed down, they can talk science.
Hope Rugo is doing the keynote speech at ASCO
The email from May 2020 makes a lot of sense taken in the context of trusted experts telling Cytodyn that leronlimab could help save lives with COVID. They were going to need a lot of money for those studies and an ambivalent FDA had no interest in helping with the funding despite the amount of it going to companies that didn't really need the cash
Sorry for the repost. Cats got to my phone while I was outside and managed to pull it back up.
No experiment is a failure that ultimately leads to success. They learned a lot and kept people alive. If they'd had access to all the safety data and could have pushed harder for additional doses for responders, they very likely could have gotten their EUA from that study. More importantly, besides the lives saved, it gave proof of concept to an idea about how not only the drug works, but how the human body works as well. This will lead to a better understanding of us. Not a failure.
No experiment is a failure that ultimately leads to success. They learned a lot and kept people alive. If they'd had access to all the safety data and could have pushed harder for additional doses for responders, they very likely could have gotten their EUA from that study. More importantly, besides the lives saved, it gave proof of concept to an idea about how not only the drug works, but how the human body works as well. This will lead to a better understanding of us. Not a failure.
Not so. The statistician was at Amarex. The statistical analysis plan didn't provide for the possible sub analyses, so the study took a statistical hit when the signal was seen and a decision was made to perform to he sub analyses. They were pretty close, so they might have skated by if they'd had a more robust SAP - one also allowing for meta analyses so data could be pooled across studies to look for signals
Yes. The FDA wanted the safety data reviewed across all studies and, I believe, all indications. Amarex specifically said they were maintaining and reviewing safety data. Nadar specifically said Amarex was withholding the safety data they needed for the FDA as a big reason they were suing Amarex for access to the database. Cytodyn was unable to complete the review of the safety data without that level of access to the databases so they could pull safety data from across studies and make sure there were no missed safety concerns. Drugs that target the immune system are notoriously prone to side effects. It's understandable why the FDA would want to be cautious about giving it to very sick, unhealthy people without that data. If you look back, that was the fight all along. Now it's being reviewed by a new pharmacovigilence CRO. It's been long enough imo, that if there was a clear signal of safety concerns, other studies would be put on hold. I think it's just about waiting for the process to complete. Could be any time now, but they may wait to give it to the FDA first
The FDA was still asking for the safety data from Amarex at that point. With that data, Cytodyn would likely have had an easier time getting the 4 doses approved
Veru hasn't claimed statistical significance, but clinical and statistical meaningfulness. FDA said they could submit because their efficacy and safety warranted it. They wan to see leronlimab's combined safety data. We are about at the 6 week time point for the safety analysis SK said should take 8 to 10 weeks. The FDA is still accepting EUA submissions for COVID. The long hauler study shows why leronlimab may work in a subset of patients. As long as there are blood samples available, a post hoc analysis can be done to see if that can help explain the leronlimab results. I don't think Cytodyn should start a new study without an EUA in hand, but there's no reason the UCLA post fellowship program can't take a look at those blood samples if they haven't already.
Culper's put out a short report on them saying they were unlikely to get the nod from the FDA based on "manipulation" of the data and poor management. That was back on May 2nd. Maybe there's been some shaking up of cozy relationships......
Leronlimab has an abstract publication at ASCO for the pooled breast cancer dats
The HIV reference bis probably as simple as the miscommunication between FDA and Amarex about whether the FDA had all the safety data it wanted in the appropriate format. The company did reference the safety of the product regularly. I would imagine it all goes back to that. Kelly said it would take the new pharmacovigilence CRO 8 to 12 weeks to fully analyze. That was at the end of March. If there were any concerning signals that were missed by not properly aggregating the data, we should know by then. It necessary box to check and is understandable why someone was pushing for it.
And, good posters end up on investigators walls and in the hallways of institutions after the conference. People do stop to read those.
It's a poster, but with the 101 spot. If that lands it at the entrance to the poster session, it means lots of passerby eyes on it - not just people who planned to go through all of them. Get those introverts interested.
I believe the long hauler paper addresses the issue
Little Britain Road is an old road in New Windsor. Looks like they created International Blvd at Stewart Airport when they expanded it from the old air force base to the 4th NYC region International Airport. Stewart is technically in Newburgh. Other possibly is the guy's wife owns a nail salon and he gets free rent and possible foot massages during his downtime
Is that a Biogen SEC document? They partnered with AGTC in 2915 for $124 million on an option treatment
Haven't seen the vulture lawyers around, though.
The refuse to file letter from the FDA and legal filings from the proceedings with the 13d group over being added to the proxy card for the board of directors positions and communications from the 13d group themselves.
I never said that. I really don't care what he said. I also never questioned his abilities as a clinician.
Leronlimab works because it works. This has been shown in multiple clinical trials in multiple indications. There's no way to know if it has a sustained response with Covid because of the study design flaw. However, the design did show that while on leronlimab, viral loads were reduced and fewer patients died. Once they were taken off, the death rate rose to that of placebo. Since there was no restrictions on other medications, the one thing that was confirmed to change for all patients who were not on placebo was reduction in exposure to leronlimab.
It was also Bruce Patterson's receptor occupancy test the FDA wouldn't accept as valid at a time when Bruce Patterson's was trying to force Cytodyn to buy his company for $350 million. It was also Bruce Patterson that the 13d group wanted to have hired by Cytodyn because they said he had strong connections at the FDA and could get the drug approved.
FDA wanted that dosing at a time Bruce Patterson was making a false patent claim for leronlimab dosing for Covid 19.
Down to 3.3 million shares available to short. Each time the lot is returned, there are fewer shares - by millions sometimes. I've been buying 100 or 200 at a time. The day they clear, they are borrowed - everytime. Squeeze baby squeeze
A better drug doesn't need any underhanded activity to get patients.
No.
He would have signed form FDA356h at most - especially if signing for the fees paid. They got approval to submit for a cheaper fee because they're a small company. A BLA is comprised of many documents and many people sign off on various things along the way. The focus on NP signing this doesn't really make sense. It's scraping the bottom of the barrel for things to complain about.
BLA submissions are all electronic these days.
Then Amarex should have responded that they couldn't file it because of defects and list them out. Then Cytodyn could have known earlier what the issues were and gotten them addressed before it impacted their reputation.
Go ahead and tell cops that someone told you to hack into someone's phone and, therefore, they broke the law and not you when you did it.
I don't recall seeing or hearing about an email from Amarex to Cytodyn delineating the deficiencies that would prevent them from submitting the BLA.
They have the EDC system and TMF. Those are obviously in the MSA. You can refer to Cytodyn vs. Amarex for proof. The data in the EDC was not appropriately transferred to the FDA during the BLA submission. Amarex wouldn't allow Cytodyn to have the database, so they were solely responsible for all clinical data in the BLA. Do you even know what is included in a BLA?