(Total Views: 620)
Posted On: 05/11/2020 9:11:23 PM
Post# of 154721
Evil
I am very long this stock and very much combo to be approved but you need to stop berating the people who complain about the BLA not really being done and stop making the FDA the villain.
We should just look at the facts. From the PR, it says the at they need to submit information in the format requested in March.
If you look at your dates you will find that the BLA was submitted in April which is after March last time I checked. This is after we heard that theBLA was initially delayed because the fda asked for the data from the two trials to be reformatted so that they could be analyzed as though they were from one trial. We even heard that Amarex did it both way A and way B so that once the fda decided how they wants people to see it we would be ready to submit right away.
From what we can tell from the PR’s the data was not in the format requested in March.
Before you pen a nasty reply think about it from a neutral perspective and from the FDA perspective.
We need to discuss facts and until someone clarifies what was written this is the logical conclusion that i draw from the available information even though i don’t like the conclusion.
IMO
I am very long this stock and very much combo to be approved but you need to stop berating the people who complain about the BLA not really being done and stop making the FDA the villain.
We should just look at the facts. From the PR, it says the at they need to submit information in the format requested in March.
If you look at your dates you will find that the BLA was submitted in April which is after March last time I checked. This is after we heard that theBLA was initially delayed because the fda asked for the data from the two trials to be reformatted so that they could be analyzed as though they were from one trial. We even heard that Amarex did it both way A and way B so that once the fda decided how they wants people to see it we would be ready to submit right away.
From what we can tell from the PR’s the data was not in the format requested in March.
Before you pen a nasty reply think about it from a neutral perspective and from the FDA perspective.
We need to discuss facts and until someone clarifies what was written this is the logical conclusion that i draw from the available information even though i don’t like the conclusion.
IMO
(9)
(0)
