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Exactly, both the MHRA and Canada will consider the open label patients data. Over 87% of Canada's cases right now are the P1 variant (from Brazil) which has escaped the vaccine. Even if a trial is required in Canada, they have provisions to allow the drug to be sold while awaiting approval. Leronlimab will be in high demand in my opinion.
I agree with you. The releases on both sides were very unprofessional and damaging to the companies. They should have resolved this behind closed doors.
I agree, interesting timing Bob1968. Lots of things coming together around the same time: lackluster 28 day IV data, determination that they needed to develop a more shelf stable IV product, etc. Perhaps Relief felt that the inhaled market was a quicker/better route to market and went in that direction instead. NeuroRX continued on with IV because they were mid-trial and waiting for 60 day data. Partnered with TFF for powdered version. Should be a win-win for everyone if any of these different formulations gets approved.
Yes, I agree that the inhaled version is going to be the key, so I'm glad that Relief didn't wait for the U.S. FDA and started their own inhaler trials in the EU. Picking up Acer's inhaled patent was a smart move. It's much better to catch the covid patient before they become critical, and the inhaled version can do that in a cost effective way.
In the U.S., it's going to be an uphill climb to unseat FDA/Fauci's darling Remdesivir for standard of care. Remdesivir failed multiple trials and even the WHO warned against it's use, but that still has not stopped it here in the U.S. The NIH trial pairing Aviptadil with/against Remdesivir will hopefully solve the Remdesivir issue once and for all, but it's going to take awhile. I expect that RLF will get revenue from the EU before the NIH trial is finished.
Exactly Bob1968! LOL. Shooting themselves in the foot for sure.
Here's the good news, if the drug works as well as we've been led to believe, there will be an awfully big pot of riches, so there should be enough to go around. GEM will make sure they get it all sorted out. Too bad they had to do this publicly, however. Not a good look for anyone.
I think covid drug approvals are taking longer than anyone ever expected. I'm sure Javitt thought he could circumvent the usual blinded study with his open label study, I mean it was a pandemic after all, but it didn't work. The FDA ignored their own guidelines that for an EUA your drug must only be "proven safe and may be effective." All of the trials are getting drawn out and costing more than expected.
My personal speculation: NeuroRX is holding the data until their merger with BRPA is complete so they can be listed on a major exchange before the PR cycle starts. These issues with RLF are very minor, considering the billions at stake here. Sounds like to me they are attempting to withhold the data so they can control the release, and they are using the unpaid bills as an excuse to withhold it, meanwhile dragging their feet on providing backup for their invoices.
This is a business, and in business you must have receipts. You can't just say "pay me 4 million dollars" with no back up and expect to get paid, especially when you are 30%+ over budget.
You also can't legally withhold data you were paid to collect, which is what NeuroRX is doing right now. They were under contract to perform the trial and share the data with RLF. They are literally holding the data hostage trying to position themselves for a higher reward, while also disparaging RLF publicly. Tacky and unprofessional.
Thank you Ria2 for providing that link to significant shareholders. It's very helpful. With all this discussion about issues between RLF and NeuroRX, the most important part to remember is GEM is heavily invested in both companies. They will make this partnership a success one way or another. :)
Can anyone tell me where to find out how many shares of RLF are held by GEM. At one time, I heard it was about 46% but is there a website where I can check? I wasn't able to find it on Fintel. https://fintel.io/so/ch/rlf
Exactly J-Belfort! Thank you for always cutting through the BS around here.
Fitbit, it's also possible that the original contract included an agreed upon price and timeframe for the trial, and JJ was unable to deliver. If you recall, JJ was quite confident early on that we'd be getting an EUA quickly, based on just open label, compassionate data and safety data, but it didn't happen.
I don't blame JJ as there is a pandemic after all, so one would expect the FDA to jump on any safe treatment that showed promise, but that wasn't the case. It appears he was unable to break through the big pharma stronghold at the FDA, even with the senator on the committee and all their prior experience.
So it sounds like to me, there needs to be some more negotiations between RLF and NeuroRX. This is taking longer and costing more than anyone anticipated.
Institutional Ownership?
Can anyone point me to an official document or website that includes the the number of shares currently owned by Gem? I could not find them on the fintel site, but perhaps I am looking in the wrong place? This is my first Swiss stock. I've read it is somewhere in the 46% range, but I'd like to confirm that is still the case. Thanks.
https://fintel.io/so/ch/rlf
I love that quote BBalls! Wonderful!
"It's not the size of the dog in the fight, it's the size of the fight in the dog." Mark Twain
I've been invested in pre-revenue biotech before and this "management must be replaced" argument is right out of the big pharma buyout playbook. If you're a big pharma company and there's a small biotech company with a promising drug, and you want to buy them, but there's a management team in place that's savvy enough to know how much it's worth, big pharma will work to discredit management, erode shareholder confidence and then use them to vote to replace management. Then in strolls a new CEO more friendly to big pharma and a buyout will be immediately announced at a much lower price than expected.
Sorry, I'd much rather keep Dr. Pourhassan and Kelly. In my opinion, they care about the drug, the patients and about shareholder value.
Couldn't miss this part of the announcement: "Therefore, empiric treatment with monoclonal antibody therapies that are expected to work broadly against all variants across the nation should be used to reduce the likelihood of treatment failure."
Um, hello FDA? Wouldn't that be Leronlimab? No worries, we'll get there eventually.
I agree. Wasn't there about 65 potential indications at last count?
Did the HGEN board get closed down? Why are so many posters on here pushing Lenzilumab?
On April 15, 2020 the CD-12 trial protocol was modified on clinicaltrials.gov
It's now been changed to: “A single arm, non randomized, open label phase is added to the protocol after completion of enrollment in the randomized phase of the study.”
The group tested has a "maximum age of 65."
If you recall, Cytodyn ended up with 3 times the number of patients over the age of 65 in their blinded trial, yet they still managed to show benefit.
In my opinion, it sounds like the FDA is allowing them to use OLE data to reach the p value/number of patients necessary for EUA approval. Using OLE patients makes sense because it's not ethical to require a placebo arm when you know there is a significant mortality benefit to the use of the drug.
It's an intermediate step. The merging company hasn't been announced yet.
You're right Misiu143, it's 100,000 doses in 12 months. I don't believe Lenzilumab is going to be viable for standard of care. Manufacturing is a consideration when going for drug approvals.
That's what happened to Oncoimmune. The drug was working but the original small pharma company had to make each dose individually and had no way to scale it. Merck partnered with them with the hopes of ramping up production but they were unable to do it efficiently. They recently scrapped the program as it would take too much time and research to bring it to market.
While I do believe Lenzilumab will be effective for about 25 percent of non-critical patients, I'm not sure how widespread the use of Lenzilumab is going to be. Apparently, it's going to take them all of 2021 to manufacture only 100,000 doses. Compare that to Leronlimab, which is not only more effective in moderate, severe and critical patients, it's available in quantities of millions of doses per month. Big difference. https://www.genengnews.com/news/humanigen-neurorx-plan-fda-emergency-use-filings-for-covid-19-candidates/
Ely Lily's Bamlanivimab was revoked because it no longer worked by itself due to the mutations in the spike protein of the covid virus. They intend to use it in combination with another one of their mabs and are hoping the combination is more effective. In my opinion, any medication or vaccine designed to target the virus will have a short window of efficacy. Drug companies will forever be playing catch up to the new mutations.
The beauty of Cytodyn's Leronlimab is that it doesn't target the virus, it works directly with our bodies, so it will work no matter how the virus mutates.
Give leronlimab away for free? Really? Absolutely not. You must have missed the discussion in the recent Philippines video with Dr. Randy about the cost of Leronlimab through CSP? They discussed at length how it would be priced comparable to Remdesivir, but could be purchased for 20-25% less if bought in bulk.
Re: the former president's current condition. I understand that bacterial pneumonia is an increased risk factor with the use of Tocilizumab. Even more so with Covid patients that need intubation. https://pubmed.ncbi.nlm.nih.gov/30679153/
Exactly, and on the last Philippine doctor video they specifically discussed the cost of leronlimab. They are not getting the drug for free.
Actually, the NIH article sounds more like Aviptadil than Lenzilumab. Aviptadil protects the Alveolar cells in the lungs.
Thank you mrfumbles.
Thank you. I didn't realize the ticker change had gone through yet.
I agree. I am invested in IALS, AWGI and SENY. What happened to the IALS board? It's disappeared.
I am invested in all the Moody plays. What happened to the IALS board?
Thanks Bballs. The longhauler trial is a Phase 2 small trial used for proof of concept. They are using biomarkers to judge efficacy. What they learn will be applied to a larger Phase 3 trial.
Justdafacts, you might want to listen to that part of the call again. What Nader said was that while there isn't any such thing as a "conditional EUA" that EUA's have conditions on them and they applied for an EUA conditional on continuing the trial.
I’ve seen a lot of discussion on here blaming Nader for the trial design, but what hasn’t been considered is the fact that phase 2 trials are normally exploratory, meaning there is no difference between primary and secondary endpoints as the goal is to discover how the drug is most effective and proper dosing, and then proceed to a phase 3 based on those discoveries. Unfortunately, the demands of the pandemic resulted in a phase 2b/3 combined trial without the benefit of the knowledge normally gained in a phase 2. When you consider those factors, plus the fact that the fda did not allow the request for doses 3 and 4, that the trial was blinded to Cytodyn (unlike HGEN’s format), and the fact that the DSMB did not catch or reveal that efficacy was decreasing due to half life, it’s nothing short of a miracle that Leronlimab did as well as they did . Their 82% survival benefit for critical patients at 14 days and 24% overall, far exceeds any other drug. Cytodyn was literally blindfolded, with both hands tied behind their backs and they still hit it out of the park.
From what I understand, clay trader is a bot that reacts to swings in volume. Our upswing today probably triggered it. There are very few shares available to borrow to use to short and the interest rate is high. They can pile on but betting Cydy will go down at this point is really risky given all the catalysts out there, don’t you think?
In my opinion, ideal news would be: EUA from FDA with Phase 4 Confirmatory trial. This would mean no placebo group, but large enough trial size for full approval.
Lenz is upstream, you say? Uh, no, you've got it backwards.
Surpassing 82% survival benefit is not an official endpoint, it's just a title of the PR. Once the protocol is approved and uploaded to clinicaltrials.gov we will be able to see the endpoints.
If insiders were selling there would be Form 4 SEC documents filed. There have been none. More likely, hedge funds covering while trying not to drive the price up.
T-trades are used to make large purchases and sales throughout the day without moving the stock price. Hedge funds use them to cover their short positions. They drop the stock price early, and then trade on the weighted average all day.