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Posted On: 04/21/2024 2:56:39 PM
Post# of 148870
Regarding the last part of your post, I don’t think it was Dr Jay’s communications at all that resulted in “The Letter”: The previous blunders, amateur approaches and incomplete/mis-formatted BLA filings as well as blatantly ignoring the FDA warnings contributed. The bogus press releases and Proactive videos made anyone with knowledge of the rules that are expected in PhRMA/Biotech and regulatory affairs, cringe as they were so out of line with what can legally (jmo - not legal advice) be said from a company either developing a drug or one that has already been approved.
It is a very serious offense to misrepresent a drug before it has passed certain hurdles established by the FDA. That is not a slight whatsoever on the efficacy of LL and what we all were witnessing across multiple disease states. You just can’t use words like (these are my words)- Amazing, Better, Beautiful…; this is a standard (and bare minimum) understanding in the Industry and NP didn’t get that. The Amerex debacle made things terrible for LL to get approved.
Then there was a pitchforks and torches period where mob mentality ruled and cydy enthusiasts were pressing to write the FDA and demand approval, without LL having passed the proper regulatory hurdles. The FDA took this to mean thar NP ‘s premature and out of bounds languaging was getting through to the “Lay” (their word from the letter) and they have to take that seriously because it, again, Hadn’t gone through the proper regulatory process and cross the proper hurdles to obtain approval.
What is the letter harsh? Absolutely. Could it have been handled a different way? Absolutely. I disagree with many of the characterizations of LL in that letter, but the letter was not caused by Dr. Jay. It was years in the making from the fumblers of Amerex Along with the points that I have noted above.
*I again implore folks to let SA handle things.
Having said that I am 100% confident that Dr. Jay is the right man for the job and I say this because of the way he speaks. Like it or not, he has to be respectful of the FDA and he has to speak and write in a language that Does not trigger them. They are bureaucrats and they work under a system. That system has certain steps that must occur and If you step out of line, they will push back. Dr. Jay understands this and his experience in clinical trials and regulatory affairs of drug approvals are a godsend to our cause. His passion for improving, the lives of patience is a bonus to say the least.
It is a very serious offense to misrepresent a drug before it has passed certain hurdles established by the FDA. That is not a slight whatsoever on the efficacy of LL and what we all were witnessing across multiple disease states. You just can’t use words like (these are my words)- Amazing, Better, Beautiful…; this is a standard (and bare minimum) understanding in the Industry and NP didn’t get that. The Amerex debacle made things terrible for LL to get approved.
Then there was a pitchforks and torches period where mob mentality ruled and cydy enthusiasts were pressing to write the FDA and demand approval, without LL having passed the proper regulatory hurdles. The FDA took this to mean thar NP ‘s premature and out of bounds languaging was getting through to the “Lay” (their word from the letter) and they have to take that seriously because it, again, Hadn’t gone through the proper regulatory process and cross the proper hurdles to obtain approval.
What is the letter harsh? Absolutely. Could it have been handled a different way? Absolutely. I disagree with many of the characterizations of LL in that letter, but the letter was not caused by Dr. Jay. It was years in the making from the fumblers of Amerex Along with the points that I have noted above.
*I again implore folks to let SA handle things.
Having said that I am 100% confident that Dr. Jay is the right man for the job and I say this because of the way he speaks. Like it or not, he has to be respectful of the FDA and he has to speak and write in a language that Does not trigger them. They are bureaucrats and they work under a system. That system has certain steps that must occur and If you step out of line, they will push back. Dr. Jay understands this and his experience in clinical trials and regulatory affairs of drug approvals are a godsend to our cause. His passion for improving, the lives of patience is a bonus to say the least.
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