What gives you the right to pass judgement on Nade
Post# of 154810
(Total Views: 544)
Posted On: 05/01/2022 2:39:14 PM
What gives you the right to pass judgement on Nader for the BLA being submitted before the corrupt Amarex had 2 years to remedy the issues that were itemized by the FDA? Is it not Amarex that shares most of the blame? When it is all said and done will Nader share most of the blame for the 2 years that Amarex did virtually nothing? How long are we to wait for a specialized hired talent to submit a corrected BLA application? When the FDA gave Amarex a written description of all the faults that needed corrected. They couldn’t keep a lead person on the task of correcting the BLA for submittal.
Does anyone know or remember that we had a rolling review with fast tracked designation approved by the FDA. So when we talk about who dropped the ball. Might want to look at why wasn’t the rolling review used? Seems this is a check off of all sections of a application one by one with structure and some reinsurance of a completed correct BLA as your final ending. With the chance to correct each section after being reviewed. How much easier can the process be for Amarex. Why didn’t they use this process?
When it all comes down and Sidley settles this dispute about the liabilities that Amarex has. I am sure we will be on the best side of it all. Clearly something is fishy in all of this. A frustrated email taken out of context will not allow Amarex to shrug their liability in all of this. I believe they hold more than their share of not all the liability in this failed BLA. Only time will tell.
This is just my opinion and with my opinion and a buck fifty you can buy a cup of coffee most places. Just regular brew not a Starbucks specialty coffee of coarse.
Does anyone know or remember that we had a rolling review with fast tracked designation approved by the FDA. So when we talk about who dropped the ball. Might want to look at why wasn’t the rolling review used? Seems this is a check off of all sections of a application one by one with structure and some reinsurance of a completed correct BLA as your final ending. With the chance to correct each section after being reviewed. How much easier can the process be for Amarex. Why didn’t they use this process?
When it all comes down and Sidley settles this dispute about the liabilities that Amarex has. I am sure we will be on the best side of it all. Clearly something is fishy in all of this. A frustrated email taken out of context will not allow Amarex to shrug their liability in all of this. I believe they hold more than their share of not all the liability in this failed BLA. Only time will tell.
This is just my opinion and with my opinion and a buck fifty you can buy a cup of coffee most places. Just regular brew not a Starbucks specialty coffee of coarse.
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