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Stervc, I don't think they have an FDA submission. They are using or have used an FDA approved protocol that companies use for medical devices as stated but they do not say that they have discussed any protocol or testing or submission for approval with the FDA.. It may very well be that they do not need FDA approval at all for this product but are using a standard recognized by a serious regulator to give credibility to the data and subsequent analysis. This is what I get from their text.
All Cyrus has to do is take Leronlimab and he is back to work. Come on man!
My buys @ 0.006. Odd that price dropped.
Jail for both is my preference. Too many lies and deception.
Now for jail time for both NP and SK. Scoundrels both. The SK indictment can’t be far behind the NP indictment.
Perfect!
That was not a call at all. They might as well just leave it at the PR. No questions and no discussions.
No excitement at all from the new top guy. He sounded more frustrated than anything because he was asked to read a prepared statement.
Leronlimab cannot hear you. And feelings have nothing to do with it. Just dollars and cents. The company that makes best use of cash to deliver actionable results wins. In biotech only FDA approval and sales means anything. Management just bumped their gums for years while stealing shareholders money.
No amount of cheering for Leronlimab can save this company. No money, no trials, no approvals = dead company!
How could LL be approved years ago for HIV if no BLA was ever filed?
No evidence the Brazil trials are back on. More hopium.
There is no strategy behind filing a 10K. It is a requirement by SEC rules. The data in it must be accurate or lawsuits and penalties will follow. That's it.
Pure hopium! Now bad news is good news? Cyrus is there because he is getting paid. He is not working for free. As long as the 350MM shares are approved his gravy train keeps rolling.
It’s all over now. The price is high enough to short back down to 0.2 and make decent gains. No catalysts on the horizon to make this do anything but drop. Shower sellers dream.
You mean the "good news" that they have to enroll another 25 patients for 24 weeks to get proper data to validate the HIV trial data.
I am sure they need to do this to get the ROT and the safety data that is now trashed.
They will have to ask for 500 million shares and they know it. Time will tell
They will ask for another 500 million. 200 will be gone in a matter of weeks. They need more time to enrich themselves and hope the FDA plays nice.
Even 500 million won’t be enough to stave off defeat. Listen to the tone of Ms Urbach on the call. She is dead tired of all this and is probably wondering what she signed up for.
Their salaries are already smaller than when they were awarded shares in lieu. They will be sellers for sure. That will not work for free or deferred payment.
There is only a pending partnership with the bankruptcy court. NASH is over for CYDY. The RCT trial failed as the company said. The 350mg group now seems like noise and BP is not interested in that.
Leronlimab now seems destined to be a lab drug for universities to play around with now and then - but that it about it.
This exactly the point: CYDY did not have and still does not have a competent CMO to speak with the FDA about MoA etc
The importance of this role was/is clearly lost on NP and current management.
Who is responsible for making the FDA aware of the MoA of the drug for a particular illness? In this case CYDY - clearly they were not able to show this at the time.
Read the trend in deaths due to Covid. Are they going up?
To be clear: the COVID play for CYDY is over because their is no longer a need for a therapeutic. If it was not needed last year it certainly is not needed today.
CYDY does not make vaccines
Excess death - deaths above the expected annual numbers/trends due to endemic diseases and illnesses.
So for context a pandemic comes along and MORE people die beyond the expected.
e.g Covid and the additional ~1 million Americans dead
Not rocket science........
The infection rate is inconsequential if there is no accompanying increase from n hospitalizations and death.
All emergency temporary hospitals and treatment centers are gone.
So it won’t matter if 1million per day are infected as long as hospitals run normally and no excess deaths.
COVID is over!
Covid is over. The world has already opened up and moved on. No country is concerned about infection rates anymore. Even the news cycle has turned.
Death rates are acceptable - yes, acceptable by the powers that be. So they will not spend largely on any COVID-19 response anymore.
Not that nonsense again about "presenting at conference so the data is good:". The conference has nothing to do with "data is good". They are presenting or poster placing because they want visibility in the NASH community - that is as much as you can get from it. Nothing linked to partnership or buyout.
Is that what NP said happened? Based on his historical economics with the truth, well I rest my case.
That is a good question for NP. However, it could not be that the FDA did not accept the BLA as it was never prepared. Even until today.
We can go down this rabbit hole but no comparison can be made here. As I recall the FDA's own advisory panel recommended against it and that decision was overridden by key decision makers. Said advisors subsequently resigned.
Now these advisors were reviewing data provide from the trials and reviewed and concluded it was not ok.
To my knowledge CYDY hs not presented a BLA package worth reviewing for sucha decision to be made.
The point being that if you do not follow the process you have NO CHANCE of approval even with a good drug. If you do follow the process you have a chance of getting an "executive approval" even if you fail the advisory review.
Where is CYDY with their BLA?
It was not approved because as of today no viable BLA has been provided to the FDA. Do you expect that the FDA would just approve it because CYDY says so, without evaluating the BLA data?
Where is the stat sig p-value? Regulators will not consider, much less approve a drug that did not deliver a stat sig p-value.
Don't get distracted by Remdesivir approval - focus on Leronlimab and its trials.
Remdesivir delivered p-value for the trial end point selected and was approved - not that I support it or like it but that is the fact.
Leronlimab has not delivered a stat sig p-value in any PH3 Covid trial. NASH trial was PH2 and so no p-value was expected .
Leronlimab has not been trialed in PH3 for any indication other than HIV and COVID.
Do not get confused by conference attendance. PH2 complete data IF presented has no approvable data by definition. So tell me again what data are you talking about that is so strong?
I am curious to know what has been proven with the drug so far.
Even the HIV trial data is suspect because of the CRO actions.
What other completed trial delivered efficacy and p-value so that you can say “proven”?
None that I am aware of so far.
Anyone with biotech experience would have been better than NP - he was that bad.
The fact that those like Dr Jay and Dr Pestell are now willing to engage with CYDY in the post-NP era means that even the company recognizes how awful NP really was.
SK is next for “personal reasons”.
Why are you still believing in what SK says is a real mystery!
The players in this CYDY game are still lying like hell.
There is no partnership and no BO. CYDY does not have usable data to show to any potential partner. The CRO debacle means the exiting mess of “data” cannot be trusted.
The company has declared that NP is the proverbial fly in the ointment. They now recognize that Pestell is well recognized by the establishment. All of a sudden they regret all that NP said about him. Only now they could see NP for the professional idiot that he is - no knowledge, experience or anything to do with biotech and yet had the gall to criticize Pestell without merit. This pretty much sets up SK for a "personal reasons" exit as the final lines of the apology.
We do not know what CYDY presented to FDA as justification for 4-doses. Why?
Because the company did not and still does not have a competent CMO to interface with the FDA.
If as you say CYDY provided the FDA with the dose escalation safety and efficacy......either you don't know or the FDA officially lied when they said in the letter that they did not get the safety data aggregated for HIV - and hence halted HIV trials.
What say you?
Big pharma do not take risks like that. They prefer to pay a premium than to take a risk like that. An yes, listen to Dr Jay, the team at CYDY was/is inept as the same management is in place minus the CEO. The same people are managing the business.
Nothing in there says the company can survive. The SEC filed records say the company is not going to make it. Note I said the company. The drug MAY survive if a company wants to play with it. There are no partnership talks because there is no data to share. As long as Amarex is holding/analyzing/massaging data from the trials that have been completed the data will be suspect.
My take is that CYDY is trying theor level best to salvage the data from Amarex but it may be too much for them.
Incompetence is a heavy burden on this company. Sorry C-20, wishing and hoping will not cut it.
CMC is not safety data. That is about manufacturing, packaging etc. Safety is part of the clinical package. That is outstanding. In fact the last FDA letter cited the lack of aggregated safety data as the reason for the HIV trial halt.