Stop blaming the FDA for lack of regulatory approvals for CYDY.
A very close friend is CEO of a small pharma company that has filed for a BLA of a new drug in the cancer space. He noted the FDAextremely helpful in providing guidance, yet is rigorous in their demands that guidelines and requirements be met to perfection. One of the original submissions was “telegraphed” by FDA for an RTF. He pulled the application, Received and Applied their guidance and has resubmitted.
Why are all the executives with pharma experience gone from CYDY?
NP is not a craftsman. He is a “huckster” and promoter who will not or cannot follow directions. He is trying to FORCE anecdotal info down the throats of regulators instead of following rules. EVEN Nader complements the FDA. Obviously, it would be extremely counterproductive do knock the FDA on a CC, but guess what, they ain’t listening to a CYDY CC. So why lie? He can just NOT comment on the FDA at all. Does he just feel compelled to constantly lie?
Big pharma no doubt receives preferential treatment from FDA. According to CYDY former COB and former head of Gilead worldwide manufacturing, Gilead has dozens of if not hundreds of scientists working on submissions to FDA. The submissions and communications are well crafted and followed through with the utmost professionalism. So... based on this army of experts Big Pharma gets the benefit of the doubt.
We have seen Nader operate and communicate( actually fail to communicate), as well as numerous failed Trials and analyses by the third party CRO hired by Nader.
NP WAS advised to use a more reputable CRO company and refused, instead hiring a a substandard company at a”cheaper cost”. Their Failed submissions and trials resulted in lack of FDA approval and that is the fault of the FDA?
How about employing a TOP TIER CRO with a proven track record.
Unscientific anecdotes are clearly not a metric the US FDA and many other countries will use in approval or EUA. But NP insists on generating and citing this type of data because that is the only realm in which he can operate. He is out of his depth with details and the company needs an EXPERIENCED PHARMA EXECUTIVE ASAP.
Here is an analogy:
I live in a city that has a fairly active port. The captains that operate the ocean going vessels are generally top notch professionals (that does not apply to NP). Before those ships can enter our port, a local HARBOR PILOT boards the ship to guide it in. He is an expert in the local environment.
Until we hire a true expert in trial data analysis and submissions, somewhere in the chain of CYDY performance, The FDA gets a pass. Color within the lines, dot all the I’s, cross all the T’s and then see what happens. CYDY has never done that.
I do not doubt NP works hard, but that is not enough. When you are a small company you must be perfect in the details and execution ...is there any proof, at all anywhere that perfect in details is in Nader’s wheelhouse?
Submit a study that checks all the boxes.
The scrutiny will be even greater on CYDY going forward, due to failure upon failure and the social media war that has been foisted upon the FDA.
We are on the FDA’s radar, but for all the wrong reasons.
I am long. Have been long since 2012. I know the science is real. The Excutive team and BOD is holding back the performance of LL.
And...don’t get me started about SK presenting cancer info to oncologists ( see dictionary for sh#t show)
