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Do you have any link to the update?
thx
Kelly has no credibility, every word which comes out of his mouth comes with the flavour of the past. For much too long he was the willing cheerleader of Nader and I will not forget how they (Nader and Kelly) tried to grant themselfe with the BOD shares and salary raises while the company had no revenues and was low on cash.
At least I hope they let him NOT talk this cheap potential partnership shit (he is talking about this carrot for more than two years?).
I do not know what he brings to the table which could outweight his past actions. Why is he still CMO, wasn't the AMAREX desaster enough damage?
You mean this will fly like a bunch of flies circling around a big smelly turd?
You were one of the greatest Nader fanboy until you sold your shares. You had for every delay and failure an excuse back then.
Yeah sure
Investment by NSF International in Amarex
So what are those 50+ trial sites now doing the whole day? Are those sites not operational or just on the paper active?
I cannot belive with currently 200+ covid deaths per day in brazil, that we cannot get 4 or 5 patients a day.
I do not believe it is a money issue (not even Nader would start a trial without a proper budget for the next few months)
Why would BIOMM add/ recruit additional trial sites if CYDY would not be able to afford the 20+ trial sites they had in the beginning?
Does not add up, I suspect other issue(s) than money and lack of COVID patients.
I am not up-to-date. End of November beginning of December they will release the NASH data or do the data analysis is started?
I couldn't agree more.
The market has zero confidence that the company can push anything over the finish line. It seems that every new trial is another distraction for shareholder and management, which was already over its head with HIV BLA and cancer trial in the pipeline.
Is this good news (no need of this kind of fund raising, they found a better way now) or bad news (no interest of any investor since they sold 0 shares over a long period)
I do not understand why he need a COVID spike in brazil to speed up enrollment. We have more than 12.000 cases/ day (most cases in the big cities where Albert Einstein is located).With 20+ enrollment sites he should be able to enroll 20 patients/ day or lets say approx. 100 patients/ week. What does he need, 120.000 new cases/ day?
I also do not understand why he went full risk with IV instead of SC for the critical trial. We are delayed for approx. 2 months now, what is going on?
Why take this risk? If SC critical trial is successful with 4 doses (common understanding) and we can finally sell our product in quantity he can do an IV trial afterwards.
We will get an approval with a p value of <0.05, we do not need a p value of < 0.000001
This is an unnecessary delay!
In Brazil there are currently 322 COVID related deaths/ day (7-day average) and 9982 new COVID cases per day (7 day average)
In Sao Paulo alone 889 new cases/ day (7 day average) and 49 deaths/ day (7 day average)
We have approx. 25 enrolling hospitals and we have problems to enroll patients? Really?
Where are the majority of those Albert Einstein hospitals? In the deep Brazilian jungle or in the major cities of Brazil?
How many enrolling hospitals did we have for CD12 and how many did we enroll from November to December 2020?
This does not add up!
Are we going to wait until end of November and then take action, like we did with CD12?
Nader, find out whats going on or what does not work and FIX it.
Find solutions and not excuses!
What is the status of the critical brazil trial?
As far as I can remember, the trial was approved by ANVISA after the additional information about IV.
Is LL stuck at the brazil customs, or are they already enrolling patients?
I am a little bit curious since Nader shares so little information about brazil trials in the last interviews.
If I remember correctly, during CD12 Nader was sleeping behind the wheel and CD12 only took off when they hired someone to travel to the enrolling hospitals. Did Nader drop the ball again in brazil?
What are they talking with BIOMM now in their twice per week meetings?
With "all the people" you mean yourselve and Suvorov?
Afaik Suvorov was doing some "exploring" by himself lately.
Does anybody have an overview in which Brazilian states/ regions the Albert Einstein hospitals are located or concentrated?
I would like to check the covid statistics for this regions and how they are trending.
Yeah, smoking hot like a dumpster fire ...
If 13d group lose the battle against CYDY in Delaware (in my opinion very likely), can CYDY reimburse at least some of their legal expenses from the 13d folks? If yes, Rosenbaum better start a gofundme as soon as possible.
:)
Great, thank you!
Do you have an overview how many hospitals are on this webpage listed for each trial?
Any idea if our two trials have the same requirements to the participating hospitals? I guess the "moderate" patients are also ICU patients in brazil(?), so theoretically each hospital can run both trials(?).
I still have not figured out how this platformabrasil webpage works without having an account there and some basic Portuguese language skills.
Is there any indication, that those hospitals are already enrolling patients or are they just indicating that they are prepared/ ready to enroll patients?
So far only the "moderate" (=critical) is approved and the more important "critical" (=severe) trial is not approved by ANVISA, or did I miss something?
The US FDA is not dictating other foreign agencies, but 90% of all other countries regulators are watching closely what US FDA does and not does with certain drugs, since they (for some unknown reason) are still seen as the gold standard under the regulatory agencies worldwide.
When the US- FDA publicly send out a (hit- piece) letter, those other regulators take at least notice of that and take this into certain considerations.
Not more and not less in my opinion.
Keep fighting, if he is 50% the fighter you are, he will survive 100%!
It is so surreal that you have to wait that the condition of a patient deteriorates to some point where he is eligible for right to try.
This is pure cruelty!
The worst about it, even if a patient recovers swiftly after LL, it has 0.0 effect on the approval of the drug. Even if 10.000 patients would recover due to LL on EIND/ OLE.
I am wondering about the OLE and EIND statistics of LL. Will we ever see those numbers? I doubt it.
Projecting over $33 billion in COVID-19 vaccine revenue alone in 2021, CEO Albert Bourla wants to beef up Pfizer's pipeline.
Cytodyn is not mentioned, but he could catch 60+ flies with one hit.
@13d: Karma is a bitch!
Dude, they cannot even sign a document when required.
And regarding
my favorite quotes until page 9 are:
Excellent call? Confusing like most CCs, spiked with some good information from Dr. Recknor and a few good inputs from Kelly. Nader mumbels about stopping the NASH trial and a few seconds later Recknor says this is not a good idea. Was this an idea Nader developed during the CC? Unbelievable how unprepared and uncoordinated Nader is. They have not got any trial running in Brazil or have any experience with the new partners, but Nader wants to move most trials to Brazil? He has no long-term plan, jumping from one to an other thing, absolutely not fit for the job.
Nevertheless I will vote for Nader & Co. the other Clownshow how aka 13d will be more harmful than Nader.
Back then, it should have been a red flag when US FDA did not allow a 4 dose trial. Cytodyn (and also FDA or their BP prompter) knew the safety and half life of Leronlimab and the unnecessary attached risk of missing the 28 mortality endpoint due to only 2 doses.
I would like to know what Nader and Co was thinking about this topic and I would like also to know about their decision-making process.
In my opinion they should have started to investigate other options, like trials in other countries.
The brazil Lenzilumab trial tarted in August last year, our trial (perhaps) one year later ...
I should have a cup of coffee before readying anything in the morning. Combined with the endless waiting game this tricked my mind. ??
Source?
As far as I understand just the ethics committee approved the trials, but final ANVISA approval is still missing.
So if shareholders will be "impressed", then Pestell will finally give back his 20M shares and he will compensate Cytodyn for his worthless Test and the delays he caused due to his non performance?
Great!
That is the minimum what shareholders request since Pestell is part of this group. Deliver this and then present some jucy meat and we can start talking what is missing to get impressed ...
72 hours would be absolutely awesome!
I do not expect to reach the 60days limit for the ANVISA decision either, for sure they have a special team to move COVID related trials much faster.
I just think this is the last time for BP to use their influence or for US FDA to send another obscure letter.
We got four COVID related trials approved by US FDA, why should ANVISA have any major concerns?
I expect an approval within the next 2 weeks (just my guess).
This is "only" the CEP (brazil ethics committee) approval. This "only" means that ANVISA review process of the trial can start now.
Trials are not approved yet!
I assume there are different process times for COVID trials.