I don't have that view, and I don't think it was bungled, people have said they messed up because the FDA asked them to add and amend when that is how it can go when trying to get a product through as quickly as possible.
I think many have misunderstood what is going on, and anything other than an accepted FTD application was not acceptable to them.
Lol, people say they made mistakes and in reality, they literally have no idea what was lodged and they don't know why the FDA has asked for further resources.
But in the absence of actually knowing, they blame and unconstructively criticise.
An ongoing process where the FDA works with you isn't necessarily 2 points, A and B, not necessarily submit and accept.
My personal hack thoughts are that the FDA is looking at an expedited process and is therefore now adjusting the process to suit. There was a strategy re tox assessment previously put forward by the FDA which we were going with and the FDA has some adjustments now, which is how they can work, dynamically, and we cater to those adjustments if we are able to.
It's not over-complicated or negative.
The overall timeframe re USA product acceptance, if successful, may actually end up quicker than it would have been previously.
Anyway, that's me, and simply my opinion. I may be wrong, but I don't think we need a lynch mob because the FDA altered an approach that they partially designed, and then tweaked, possibly to our benefit.
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