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What they stopped the trial and deemed it unsafe. They got mm use and can't prescribe with people that need oxygen, now they can??? Ok
No, vaccines won't be available right away, and only 30% of the population will take them.
The US alone had close to 1m cases alone last week, times 4% = 40k cases. The death rate is still around 1%. The virus has mutated several times, as we are getting into flu season on top of everything. With kids coming back from college, and families spending time together for Thanksgiving. I anticipate that these numbers will increase dramatically in the US alone. The rest of the world is steadily increasing as well, several countries in lockdown until December. I think there will be a place for Leronlimab.
I only care of they announce leronlimab. I could care less if they are approving nonsense treatments that cause false hope and cost the tax payers
The point was, our directors are getting way more than multi billion companies are offering.
So the CEO of pfizer at 60% and at $44 is only $5.6m. And Nader sold his and got $12m. I think we're over paying with benefit shares.... They actually have revenue
I believe that was only on the 700mg dose, which they are re-doing. The UK will only be for 350mg.
Agreed,
We need to focus on 2 things, finishing the S/C trial and submitting the BLA, all other distractions and trials need to be put on the back burner. Mahboob is going to be focused on the BLA, if he completes it for one country it should be good for all I would suspect. I would focus on 350mg which is what the trial was set up for and leave the rest along.
Thank you as always Tom. I think that support level will be a huge ask. I see 2 scenarios playing out tomorrow. We along with the other therapeutics get a bump from this new of Eli Lilly, like the other vaccines did today, or we're going below $2 tomorrow, as bounced off $2.03 several times today, it may not take much. I hope to see the bounce.
They can still run the covid trial, mahboob is focused on HIV bla, had nothing to do with covid.
There is supposed to be a meeting with Canada tomorrow, like the UK, they will talk about submitting the BLA for HIV, and possibly Covid.
I find it pretty encouraging that the company has been in contact with Janet Woodcock, and the OWS. They are fully aware of Leronlimab. It's only matter of time.
I think some of the blame lies with the company. Why couldn't they have submitted the BLA to the UK 2 years ago at 350mg while conducting the 525mg and 750mg additional tests?
The Covid BLA? Where did you see/hear that? As far as I know we were cleared to submit the HIV BLA for 350mg. I don't think the company can even produce a Covid BLA at this point as we don't have access to the trial data.
I'm confident that the new CSO will get it done. He's successfully completed 16 BLAs, and has worked for BP's in the past. I think we're now in great hands.
Who's to say the new face they brought in won't complete the bla for 350mg and submit to the FDA as well. Our trial was set up for 350mg, we completed it as such. The FDA asked for higher dosing but was not part of original trial layout. We have a viable trial complete at 350mg. It proves safe and twice as efficient as standard care. Mahboob has successfully submitted 16 BLAs. Let's see what happens
It's currently dropped below
Yes very promising. The ability to cross the BBB is a HUGE benefit for this already safe drug. IMO we really need a BP partner for funding as well as trials and politics.
I thought eua was only granted when there was no drug previously approved?
Can we even get EUA now that they have received full approval?
Every time there is a history lesson...there is nothing good to follow.
We already had a meeting on 9-2 with them...
Don't forget we have a meeting with the MHRA on the 22nd. Our 350mg combo trial is solid, and should have been approved years ago.
I agree that we do not have the capacity for numerous trials. We need to focus on HIV, and continue the CD-12 trial if EUA is not granted. We still have a basket trial going on as well. We have limited funding, and are having a hard time with enrollment, this is the time to prioritize.
So what are your thought about this path we've set ourselves on with the Philippines?
It seems like another distributor. Similar to the American Regent deal, It is pending EUA/approval. So there is again no money involved, no EUA/approval in the Philippines. Was this really the news Nader was talking on the shareholder meeting? I certainly hope this isn't the "Big News" that he mentioned on the Fox interview.
CHIRAL PHARMA CORPORATION as Drug Importer|Wholesaler
Company Name: CHIRAL PHARMA CORPORATION
Address: P. Antonio St., cor. F. Legaspi St., Ugong, Pasig, Metro Manila
Activity: Drug Importer|Wholesaler
Owner: CHIRAL PHARMA CORPORATION
License Number: LTO-3000001899756
Validity of License: 11 November 2021
That was published in August, I thought they said it was more, I may be wrong, but nonetheless that was a hold up. NASDAQ was something I really wanted as it gave a level of credibility to the company, added some safeguards. I hope they are able to work something out. Maybe they are working out that Philippines deal to get us positive equity, and that is the hold up. I hope to hear something from that front as well. Nader stated possibly this week. Based on his history, I'm not counting on it, I think next CC there will be shareholders asking about it, and he will pivot to another topic, like Mexico, China, and the UK.
On one of the calls they stated that positive equity was needed as it was a requirement, I think we were -$4m or so and needed +$2m. I believe the company since stated they didn't want to raise capital at these levels, and since then we have closed below $3 a few times... So I don't know if that again changes the requirements needed. I'm not to confident that we are getting an uplist, it's been 11+ weeks now supposed to take 4-6 weeks. I'd rather the company focus on the BLA then uplist now anyway. If we don't get the CD-12 trail halted it's going to be a while before we get anything significant.
Traded over 2m yesterday what kind of vol are you looking for???
Tomorrow should be an eye opener. Shareholder meeting!
Anyone know what this notice of effectiveness is?
https://www.cytodyn.com/investors/sec-filings/all-sec-filings/content/9999999995-20-002582/9999999995-20-002582.pdf
Not necessarily, it could mean they are still gathering data, and going back and forth with the FDA. NOW, if by 10-10 we don't hear that it has been submitted, then yes we have an issue. We have that 30 day window where the FDA will look at everything provided and decide if we provided everything asked.
Big thing this week is will we hear a yes/no about NASDAQ. We have that shareholder meeting on Wed. If there is no news and Nader says Nasdaq is asking for more information...Then we have an issue. Personally I don't think we're going to get it. I think there is something they're not telling us, and if all we had to do is raise a small amount of capital to get positive equity then we would have.
To date we do not know if it has been submitted. The FDA gave them a 30 day window from the meeting 9-8 to get a rapid response if they met the requirements and could submit or if they still needed information. So 30 days from the meeting is 10-9.
Per the Dr. Been interview. So Nader did not say NO, Cytodyn/myself did not interfere in anyway with the paper, instead he gives a roundabout answer.
Dr. Mobeen Syed: Got it. So the last question, this may actually be a little hard, but I think that this has been asked so many times that it is interesting to us. And that is: Did someone block Doctor Patterson's paper from public publication?
Nader Pourhassan, CEO: So what is blocked? What do they mean? Blocked? Oh! Doctor Bruce Patterson has to be reached out to. To be fair to him. You can ask him that question. We enjoyed working with Dr. Patterson. Dr. Patterson had benefits for us. He is the one that gave us, told us, about the mechanism of action and what we have there already, is very strong. He was beneficial, we were beneficial to him, hopefully. We had a very [nintelligible]. W gave his laboratory a very large [order] based on how much he was getting. So, we had a good relationship, and that's all. His paper needs to be asked — our papers, we have like four or five papers that are now submitted... And we're gonna announce very soon [whether they get accepted or not.] And we have the CD
Per a conversation with Dr. Yo. posted on the FB group, they did twice on the Lancet and Nature, Bruce is going to re-write excluding Naders name.