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MrBobbob

09/18/25 12:56 PM

#500970 RE: LakeshoreLeo1953 #500966

We’ll have to agree to disagree.

You think he was telling a bald faced lie.

I think he was telling the truth.
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Bourbon_on_my_cornflakes

09/18/25 2:30 PM

#500982 RE: LakeshoreLeo1953 #500966

Utter nonsense:

Even Steady's suggestion "After looking at the data the EMA most likely said "we like what we see, you should file so we can take a deeper look because so far your data looks approvable." is a step too far for a regulator to take....IMHO


Regulators are not here to mislead and waste people's time and money. They dont want to waste their time and taxpayer $$ on drugs that have no chance of being approved. That is why companies meet with them before applying, to see if they are in the ballpark in terms of a chance of approval.

Nice straw man argument:

"Missling could not testify that "so and so at the EMA said by all means we want you to submit a slam dunk MAA"?


Bobbob did not say that. try reading the original post next time before commenting