Hi USS. I think it was really smart to get everyo
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Posted On: 04/18/2024 10:44:31 PM
Re: USS JOHNSTON #142480
Hi USS. I think it was really smart to get everyone who worked during the Nader days out of the company. It allows current CYDY to say to the FDA, “We are a brand new outfit and it wasn’t us who screwed things up- it was them.” I don’t think Dr Jay screwed things up back then btw.
This trial allows the FDA to say “We kept telling them the BLA was not formatted correctly, was missing parts, and was in terrible shape but they (cydy/amerex) never fixed it so its not our fault it never got filed.”
The emails are unprofessional at best but it’s hard to say what or who they were mad at and why? Although its clear Nader really irked them. My intuition says they were sick of getting a poor file of documents with missing pieces that wasn’t formatted correctly in the first place. Some of the emails where they were requesting the proper data from the company were from 2018. I’m guessing after years of dealing with circus clowns they were fed up and frustrated.
Covid comes around and they are thinking- here we go again with snake oil pitches. In one of the emails some labs were sent over from covid patients reacting well to LL and someone at the fda wanted to see the controls (there were none) before they would even consider LL.
Again, hard to say if some still hold frustration with CYDY. My gut says we will be given a fair shot for a number of reasons. 1) the holds were lifted with the help of the fda 2) dr jay speaks very respectfully of the fda 3) they held the advisory meeting last year with HIV experts and came up with a patient population (inflammation) that made sense to the fda 4) as mentioned before the fda gets an “out” and LL probably gets a fresh start 5) the fda gets to see what a sh/t show cydy and amerex were based on this trial and they realize this is a whole new team.
Suing the fda is a terrible idea. Unless you want more roadblocks. SA is an excellent outfit and they know what they are doing. Let them make the decisions regarding the law- they’ve already been paid in full to do so.
You asked so those are my two cents. GLTAL
This trial allows the FDA to say “We kept telling them the BLA was not formatted correctly, was missing parts, and was in terrible shape but they (cydy/amerex) never fixed it so its not our fault it never got filed.”
The emails are unprofessional at best but it’s hard to say what or who they were mad at and why? Although its clear Nader really irked them. My intuition says they were sick of getting a poor file of documents with missing pieces that wasn’t formatted correctly in the first place. Some of the emails where they were requesting the proper data from the company were from 2018. I’m guessing after years of dealing with circus clowns they were fed up and frustrated.
Covid comes around and they are thinking- here we go again with snake oil pitches. In one of the emails some labs were sent over from covid patients reacting well to LL and someone at the fda wanted to see the controls (there were none) before they would even consider LL.
Again, hard to say if some still hold frustration with CYDY. My gut says we will be given a fair shot for a number of reasons. 1) the holds were lifted with the help of the fda 2) dr jay speaks very respectfully of the fda 3) they held the advisory meeting last year with HIV experts and came up with a patient population (inflammation) that made sense to the fda 4) as mentioned before the fda gets an “out” and LL probably gets a fresh start 5) the fda gets to see what a sh/t show cydy and amerex were based on this trial and they realize this is a whole new team.
Suing the fda is a terrible idea. Unless you want more roadblocks. SA is an excellent outfit and they know what they are doing. Let them make the decisions regarding the law- they’ve already been paid in full to do so.
You asked so those are my two cents. GLTAL
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