AI
Saturday, November 18, 2023 10:48:48 AM
Since you can’t read
Most drug development programs require two adequate and well controlled Phase 3 studies. Generally, there is sufficient time in Phase 3 to complete the necessary clinical pharmacology studies needed to finalize sections 2.7.1 and 2.7.2 of an NDA, BLA, or MAA.
NDA, bla, maa. All similar no matter the country. My point being is that it is not a 99% chance of approval.
Now that I answered you….answer me. Is Danish wrong in saying in the initial post there is a 99% chance of approval. Simple yes or no will suffice
I’ll wait patiently for your answer.
Most drug development programs require two adequate and well controlled Phase 3 studies. Generally, there is sufficient time in Phase 3 to complete the necessary clinical pharmacology studies needed to finalize sections 2.7.1 and 2.7.2 of an NDA, BLA, or MAA.
NDA, bla, maa. All similar no matter the country. My point being is that it is not a 99% chance of approval.
Now that I answered you….answer me. Is Danish wrong in saying in the initial post there is a 99% chance of approval. Simple yes or no will suffice
I’ll wait patiently for your answer.
