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I am not blind to the fact certain criticisms are due CYDY management’s goal of turning Leronlimab into a commercial revenue generator. However, I find the consistent harping on the RTF letter to be overdone at this point. I realize when you combine this isolated event with other miscues, it’s pouring more salt on old wounds, but even the most established pharmaceutical companies aren’t immune to receiving this response from the FDA for a myriad of reasons. In a 5 minute internet search, I identified dozens of RTF letters to companies like Roche, J&J, Pfizer, Novartis, and even the FDA’s current darling SOC for Covid-19 Gilead...
Interestingly enough, Gilead’s Truvada & TMC278 received a RTF letter due to its analytical methodology/qualification data which is a far cry more troubling than f’n syringes and adding data at the FDA’s request that wasn’t a part of the BLA submission in the first place! My opinion is CYDY is approaching their response to the RTF very methodically b/c, they want to understand exactly how the FDA intends to use the 700mg dose data set and how they want to see that information illustrated. For that reason only, I’m am holding out further criticism on this topic and I would suggest others do the same.
Leronlimab ennema phase 1 trial
It’s a totally unique business model... Feuerstein and Left are trying to pull financing together
The FDA can keep saying no forever... Big Pharma better get some
Woohoo!!!
I just looked at my magic 8-ball and it said “signs point to yes”(lol)
Too much resistance @ $5.95...
Gotta get those stacks
I’ve been SPAC’n for days!!!
Gilead and others would be smart to make an aggressive acquisition play for CytoDyn or get with their CFO’s to adjust earnings projections down... Leronlimab is knocking on the FDA’s door saying... “you know you want me... I’ll be better to you than Shamdesivir ever was and there’s no side-effects... no lose proposition for you my man...” FDA can’t say no forever...
The capitulation the shorts were counting on
I’ve just kept accumulating FMCIW knowing it would eventually breakout(-;
Careful everyone... a lot of resistance at $5.95
What’s happening Norton? Long time no talk(-; Looks like the Tattooed Chef Train is ready to leave the station(lol)
Anyone have a draft of the draft Adam Feuerstein has been working on to send out following today’s CC? Asking for a friend
That type of request wouldn’t be made IMO unless there’s something coming that the shareholders will find equimenable in return
That 14A is a bold strategy cotton... has to be a precursor for good things to come... doubt Leronlimab at your own peril...
There’s been several who would question the legitimacy of this “trial”. I myself have only considered Dr. Patterson’s input stating the current trial for Lenzilumab May find difficulty reaching a statistically significant efficacy b/c, in the 100’s of patient results he view, only 20-30% would have likely benefited from their MOA. Maybe that’s why all the rumors that the patients taking Lenzilumab were “cherry picked” and there’s also a great deal of criticism for their changing the endpoint in the current trial with Remdesivir who I think may have also changed their endpoint midway through the trial. I’m actually rooting for Lenzilumab and RLF-100... we need all the arrows we can get in our doctors quivers.
I think we need Scooter’s take on this one...
I can’t believe you missed that... you usually don’t miss anything posted on this board... definitely accusations being thrown aimlessly this afternoon... kinda like when a kosher chef gets mad and starts throwing knives around the kitchen when someone forgot to buy the limes for the lime zest and capers for the salmon he was preparing the Shabbat meal.
Doing that would expose the fraud that’s taking place by the caterer with all the inside information. So many could possibly go hungry
So now we have claims Nader orchestrated a series of stock frauds... first he pumped CYDY to $3-4 and dumped all his shares... afterwards he had someone pump the shares even higher by churning & washing CYDY stock reaching a high of ~$10 and finally colluding with a known short-seller to make false claims about he and his company so they could short the stock back down to the $3 range... I couldn’t have come up with a more preposterous story if I catered the event myself.
Anything under $20 is like printing money
This is certainly tragic! It would be an additional low for AF to manipulate the facts around her case but I wouldn’t put it past him
All these questions being asked and demands being made... Send your comments to the Board of Directors
There’s no twisting of facts! The primary endpoint demonstrated clinical significance and NEWS2 secondary endpoint demonstrated statistical significance. Both of these markers would warrant a phase 3 trial on their own merits. The FDA authorized SOC shamdesivir didn’t meet its original primary endpoint in a phase 3 trial so they changed it to “trend towards” a positive result... So, are you trying to say it does or, that it doesn’t matter? I would venture to guess any doctor you come across would indicate a statistically significant NEWS2 result in any trial would be of interest!
Phase II Trials in Drug Development and Adaptive Trial Design
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609997/
CytoDyn’s NEWS2 results in Phase 2 trial warrant expansion into a Phase 3 trial at a minimum!
Let’s just say the # of ongoing trials is quite large... the attached should give you some understanding of the magnitude I’m speaking of...
https://clinicaltrials.gov/ct2/who_table
Sanofi/Regeneron’s Kevzara fails again in serious COVID-19 cases
https://pharmaphorum.com/news/sanofi-regenerons-kevzara-fails-again-in-serious-covid-19-cases/
Don’t forget, they also issued an 8-K shortly after the 10-K to address the exhibit in their distribution and supply agreement with American Regent... b/c, doing so would’ve been competitively harmful. Kinda like providing all the ingredients in a receipe for the salmon you mentioned but, not giving up the secret timing for the exact moment to add the lime zest and capers.
Genius! You have this thing figured out! Teach is Obi-Wan
Interesting interview with Dr. Harvey A. Risch from Yale School of Public Health...
Anyone heard an official response from Adam Feuerstein or STAT News regarding the investigation of their interference in an FDA clinical trial?
Please give your best shot at debunking the fact that Leronlimab blocks RANTES from binding to CCR5.... short pause.... mic drop!!!
Not sure what the concern is about a $3.00 closing price on that date... correct me if I’m wrong, NASDAQ share price requirement to uplist is “average closing price” over that said period of time, not that it closed at $3.00 on any given day...
There was a desperation in the Shamdisivir FDA expanded use for Covid. How and why was it justified? Gilead has a long history of anticompetitive behavior... Let’s see how long it takes to connect the dots to collusion by Gilead insiders at the FDA... even the fools throwing shade on them!
https://www.fool.com/investing/2020/08/29/why-gilead-sciences-stock-could-be-heading-even-lo/