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Posted On: 05/06/2021 10:25:09 PM
Post# of 148899
It wasn’t the FDA who put out a press release stating a completed BLA was submitted to the FDA (over a year ago) only to come back a short few weeks later to state that was not the case, and to then continually be followed up by more PR’s and statements, (all about as clear as mud) with still no real understanding that anyone can point to definitively as to where the company is with this matter. How in the hell is that the FDA’s fault, except in that You blame them for everything. Maybe thats why the Mod thing didn't work out so well for you, you need to have some grounding in reality.
My Point which was simply that unfortunately when management does such things, it gives the hit pieces fuel for their cause. We should at least make them come up with their own BS, but (at least in this example) its hard to argue otherwise that what they say regarding the BLA submission and all the BS that surrounding it the last few years is pretty much what happened...and continues to happen. AT this point all that can be said for certain is that it either will at some point be submitted correctly and accepted, or it will not, and thats just not a good way to operate, Blame me (or the FDA) if you want but Nader and management is responsible for it. Nader should really just not offer up anything unless and until it occurs.
My Point which was simply that unfortunately when management does such things, it gives the hit pieces fuel for their cause. We should at least make them come up with their own BS, but (at least in this example) its hard to argue otherwise that what they say regarding the BLA submission and all the BS that surrounding it the last few years is pretty much what happened...and continues to happen. AT this point all that can be said for certain is that it either will at some point be submitted correctly and accepted, or it will not, and thats just not a good way to operate, Blame me (or the FDA) if you want but Nader and management is responsible for it. Nader should really just not offer up anything unless and until it occurs.
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