After reading the Interview with the RPM, Regulato
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(Total Views: 633)
Posted On: 11/11/2023 7:13:44 PM
Re: Evil Rabbit #138928
After reading the Interview with the RPM, Regulatory Project Manager, SS, I felt there was a strong element of bias. I felt the necessary respect for the submission was lacking, and certainly, neither KK nor NP did anything to refute her sentiment. They lived up precisely to her expectation.
I hope this RPM is not involved in the decision making process to lift the hold.
She expressed many times that the CRO KK was required to relay all FDA concerns back to the sponsor NP. But KK never said anything about the discussions. Why not? Why did KK keep all the FDA concerns away from NP? Was he basking in the high degree of NP's trust and high regard for him? Was he enamored by the responsibility NP gave him, to spearhead the work to get the BLA submitted?
How many shorts were notified to short the hell out of the stock when that BLA was submitted? KK knows. Oh, the web which is weaved when planning to deceive. Chief analyst, knew exactly how incomplete that BLA was, yet he submitted it anyway, and informed all his buddies that it would 100% be rejected. Isn't that when his shares or his wife's shares were sold? This is what he did to leronlimab.
And who did leronlimab have to protect it? Nobody who knew even a lick of what he should have known in order to successfully complete the task of BLA submission. Nader knew jack shit and relied completely on KK. Scott Kelly didn't do a thing. Dr. Jay could have helped, but was only involved a short while. Chris Recknor, MD was asked to be the person of contact when he was hired.
When the culture of the drug does not coincide or gel with the culture of the Big Pharma industry, that drug has little hope. But, when the culture of the drug coincides with the culture of the people, the drug has a lot of hope because in the end, the FDA works for the people and not for BP.
I hope this RPM is not involved in the decision making process to lift the hold.
She expressed many times that the CRO KK was required to relay all FDA concerns back to the sponsor NP. But KK never said anything about the discussions. Why not? Why did KK keep all the FDA concerns away from NP? Was he basking in the high degree of NP's trust and high regard for him? Was he enamored by the responsibility NP gave him, to spearhead the work to get the BLA submitted?
How many shorts were notified to short the hell out of the stock when that BLA was submitted? KK knows. Oh, the web which is weaved when planning to deceive. Chief analyst, knew exactly how incomplete that BLA was, yet he submitted it anyway, and informed all his buddies that it would 100% be rejected. Isn't that when his shares or his wife's shares were sold? This is what he did to leronlimab.
And who did leronlimab have to protect it? Nobody who knew even a lick of what he should have known in order to successfully complete the task of BLA submission. Nader knew jack shit and relied completely on KK. Scott Kelly didn't do a thing. Dr. Jay could have helped, but was only involved a short while. Chris Recknor, MD was asked to be the person of contact when he was hired.
When the culture of the drug does not coincide or gel with the culture of the Big Pharma industry, that drug has little hope. But, when the culture of the drug coincides with the culture of the people, the drug has a lot of hope because in the end, the FDA works for the people and not for BP.
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