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Posted On: 05/05/2023 10:25:46 AM
Post# of 154890
August 1st is almost 3 full months away. It’s also not Fall which is 4 months away.
The FDA have to respond in 30 days, so unless they ask for 2-3 more things, Fall is unlikely. And if they ask for 2-3 more things, then clearly the FDA is playing games and the relationship is not repaired.
I think it IS repaired and the hold is lifted Q2.
The FDA have to respond in 30 days, so unless they ask for 2-3 more things, Fall is unlikely. And if they ask for 2-3 more things, then clearly the FDA is playing games and the relationship is not repaired.
I think it IS repaired and the hold is lifted Q2.
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