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Posted On: 07/13/2020 12:24:44 PM
Post# of 148949
Re: Bored Lawyer #42667
What I really want clarified is if the data in the M2M trial will be public this week or if it will be sent to the FDA and we won't see it 1-2 weeks later. This is exactly the PR that gets us all confused about what they mean.
The BLA problem has really changed my tone on how mgmt is handling the steps in the process, it is good to be transparent, but they need to be clear on what they mean. I don't want the future of all indications to be as drawn out as they have been with the combo HIV approval. It is really important for mgmt to show that the battle is resulting in a better approach so this typical uncertainty is not continuously being followed with delays and mistakes that they assume we all know and expect.
The BLA problem has really changed my tone on how mgmt is handling the steps in the process, it is good to be transparent, but they need to be clear on what they mean. I don't want the future of all indications to be as drawn out as they have been with the combo HIV approval. It is really important for mgmt to show that the battle is resulting in a better approach so this typical uncertainty is not continuously being followed with delays and mistakes that they assume we all know and expect.
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