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Did he also say that the second order to the Philippines was already used? I am not sure if I heard it incorrectly or not.
What DD have you done on the 13d group? Change for the sake of change is not always a good thing. Sometimes better sticking with the devil that you know.
From Yahoo.
Let's talk about Drs. Errico and Staats for a moment. These are two of the 13D nominees for the BoD. They are founders of a firm called ElectroCore, which IPO'd several years back, at an SP of about $20. Errico sits on that company's board, while Staats is that company's CMO. The price of that company currently is $1.15. A nice 90%+ drop. Ouch.
It gets better. Just a couple days ago, the did a massively dilutive equity raise at a ridiculous 32% discount to the SP on the day of the offering. Article below.
So I ask you: Is this the kind of help that CytoDyn needs? Are you up for this kind of "leadership"? Are you up for some massive dilution and value destruction? Didn't think so. Vote no on the proxy. Unless you don't like money.
https://www.benzinga.com/general/biotech/21/06/21789369/electrocore-stock-dives-on-18m-equity-raise-issued-at-deep-discount-of-32
I bought in for more then a few shares and I am liking how my investment account is looking right now, so no I am not watching my savings disappear. Up almost 50%, how about you?
From what I understand for India, I could be wrong. From my understanding they can sell as a supplement in India now, but it cannot be actively marketed as a COVID treatment unless they get an EUA. Again, only my take and I could be incorrect.
I have been in for almost a year and it has been like watching paint dry, but I think you are getting in at the right time. Pulmoheal in my opinion is getting ready to take off in India. The company has indicated that they plan on applying for an EUA and based on the limited trial results should be able to get one to be able to market as a covid treatment.
Welcome aboard.
Dad,
The Philippines is 12 hours (East Coast) ahead of us, so right now it is 6:22 am in the morning on Wednesday. The Webinar actually starts in a few hours.
Good presentation on Pulmoheal Usage. Hope Windlass is doing a knockout job with marketing the product.
Under the CSP guidelines, the Physician has to report back the results to the Philippine FDA. In my mind this is equivalent to doing an open label trial to measure results. Not a bad move on CYDY part to do this, if it will speed adoption.
How do you know that it was Fife?
Seems the meeting in New York may have been more about investors then a Pharma merger like some speculated. That would explain the investor presentation that was posted to the website. In any event, seems like it may have been other investors that were not related to the Fife funding that they have done previously. At least that is the impression, that I got from the Proactive Video.
I think it was a post on twitter from Dr. Nicholas indicating that Chrial had been contacted about how to get the drug for Indonesia and Malaysia. The post also referenced a hospital that wanted to order 200 doses to conduct a trial in comparison to Rem. I think I saw the post on the Cytodyn Facebook group.
Obviously you are not going to admit to this being conjecture and your opinion versus treating everything as fact. If someone is a supporter, automatically it is assumed there is an underlying reason for it. Yet on the HGEN board, any paper or comment by anyone is treated as the Holy Grail. How many times has the GM-CSF studies done elsewhere been cited as proof of Lenz effectiveness, yet there are several GM-CSF trials that have failed. There is a reason that the trial sites are being increased for the NIH study, need to increase enrollment to hit P value. See how assumptions work, it can go both ways. Yet no ones goes to the HGEN board to spread assumptions, but!!!
The guy with no clout that was part of the congressional hearing in the Philippines. You mean that Guy? Debunked
Diesel,
Don't you guys get why Donx4 is here. He is absolutely terrified that Leronlimab will be a success and the impact that it will have on his investment in Lenz. Why spend so much time on this board trying to discredit Leronlimab. Once Doctors see what is happening in the Philippines, there will be a rapid uptick on adoption in the SE Asia countries. Then the US FDA will have some explaining to do as to why this treatment is not approved in the US, especially as documented proof is gathered that the drug works and is saving lives. US FDA is definitely in a conundrum of their own making.
Haven't seen this posted from Yahoo Board. Things are rolling along.
https://twitter.com/Yanzi02735492/status/1384574120004923395
Great Website. Hands down to whoever created this. Gives all the information that you would ever need to know about Leronlimab.
Your Joking Right. Tell that to Gilead.
https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-announces-fourth-quarter-and-full-year-2019-financial-results
I find it very interesting that the Philippine FDA felt the need to issue a bulletin about the use of Leronlimab and that it is not yet approved. They must be getting inundated with request for the drugs usage. IMO I think this bodes well for eventual EUA approval in the Philippines as patient results start to materialize. As stated in the bulletin, the patient results have to be communicated back to the FDA from the CSP. If the miracle 28 results are positive, that is another crack in the levee.
I would suggest that you go back and read the post. Hint: 4th sentence and the explanation is there.
They were also talking about a price point of 10K per treatment. I do not see insurance paying that much if there are other viable treatments that are less expensive.
The fact that this was revoked will probably make the FDA look a lot closer at any other MAB that has the same MOA of this drug prior to any type of approval. They wouldn't want to have egg on their face twice, especially as the variants become the dominant strain.
Hopefully it does not take that long for CSP. many lives will be lost during this time period.
You are probably right. HGEN has been a dilution machine since the reverse and that always has been a little bit of a red flag for me. I understand the need to raise funds for trials, operating expenses, etc. but their fund raising has seemed like it is more then that. Why constantly dilute the shareholders if you believe that there is potential revenue in the future? Trust me, I do not like the way that CYDY has had to raise funds either. It is what it is and at the end of the day the market will reward the company that they believe has the product that will be most successful.
HGEN is $2.94 when factoring the 5 for 1. This is for a trial that allegedly met primary endpoint. Where is the remainder of the trial results? Something doesn't smell right over there. Yet someone wants to constantly come over here to say how ineffective Leronlimab is. Go wonder.
My last post for the night about the Philippines. I thought it was strange about so many request for one hospital, so I did a little digging and below is what I found. not saying that it is related, but is nice to dream.
https://www.manilatimes.net/2021/04/07/news/duterte-safe-and-in-good-health-as-security-men-catch-covid-19/861273/
One other thing about the Philippines, this is just one hospital. Press release specifically says a hospital. How many hospitals are there in the Philippines ? :)
You are spot on. I noticed the same thing. At one point, he reminded NP to not discuss on going negotiations and that any news that is released would need to be done in a public format where everyone is notified at the same time. If NP keeps having these conference calls and performing like today, his days may be numbered. I for one am tired of updates that basically accomplish nothing but accentuates the ineptitude of leadership. How you could not be prepared for the questions that came out, not like you would not know what the questions were going to be asked, since they were submitted in advance. Just goes to show a total lack of preparation, what the hell are these guys doing all day in their offices? I wish they would ask shareholders if they would like to have bi-weekly updates, I for on would vote no. Only tell me when something is accomplished, we would have been further ahead if there was not a call and they just put out the CSP in the Philippines.
I think that this development has more merit then is realized. 28 patients at one time is nothing to sneeze at, and if the results mimic the results of the first patients there could be a political ground swell in the country to approve the drug. Remember, there is not anything out there that helps the most critical and Duerte could be looking for a win. Elections are next year there and he is already taking heat for the handling of the vaccine distribution fiasco. Time will tell, but I am optimistic with this development.
Kelly cut him off at one point and indicated that they cannot reveal on-gong discussions and that any information needs to be publicly disclosed at the same time. Something could be brewing.
Wished they would not have had the conference call and just issued the PR about the 28 additional CSP patients. To have a conference call, for the sake of having a call is self defeating without any tangible updates.
Listening to the call, it appears that Scott Kelly's patience with NP is wearing thin. He has jumped in numerous times to correct NP or cut him off from saying something that he shouldn't. His days may be numbered if he keeps doing these calls.
Link please on when the FDA said CD12 did not justify an EUA
I've heard that as well, but with such a small trial if even a few received the vaccination and did recover, it could be enough to taint the results. Point is, this is something the company needs to think about if not part of the exclusion criteria.
All good questions, that need to be answered. PR does not indicate whether this is in addition to CD16/CD17 or part of these trials. I do like the move of going to the other countries. If it is in addition, what is the trial size, etc? I am concerned about the long hauler trial, with current reports indicating indicating that people are recovering after getting vaccinated. This could potentially taint the results if someone (placebo) gets a vaccination during the trial, not sure if this was an exclusion criteria or not.
Anyone that thinks that the patient in the Philippines has no bearing on approval are fooling themselves. This has the potential to release the flood gates just on the data that we are aware. Shorten length of hospital stay and now the mortally benefit that was in today's PR.
https://www.manilatimes.net/2021/03/31/news/national/hospitals-forced-to-turn-away-patients/857739/
Bill,
Wasn't Killery that received a communication from the MHRA that there was an on-going trial in the UK? Could this be part of the rolling review?
Blue,
I completely agree with your assessment. If the company was going to announce bad news and the severe group did not perform like everyone is indicating, the company would have been smart to just put that in a PR and get it behind us. The truth is, no one really knows how the severe group performed versus SOC. Remember, Nadar indicated that the overall mortality at some point was around 22%, which is pretty low in comparison to other trials that have been published. I am optimistic that the severe data is better then expected and hopefully there is a PR at some point Monday prior to the conference call. Why allocate 90 minutes to Q&A to get grilled about a failure, as far as I can recollect this is the greatest amount of time that has been allocated to Q&A. It is possible that the FDA wanted to see what subset of the trial the drugged worked on and did not feel comfortable with approving for severe due to low sample size, thus the 45 additional OLE and maybe will approve for just severe and await the additional trial data for critical. The fact the severe was not PR'd does not equal failure in my mind, no top line trial data was released.
Can someone refresh my memory on what the mortality benefit was on Remdesavir? Last time I checked, this received approval. The writing is on the wall, read the last paragraph. A recently approved Il-6 blocker reduced mortality by 2% versus standard of care. How could this even be perceived as a failure versus what has been recently approved?
Learning,
Correction on your post. Mark mandate was lifted in Mississippi not Missouri.