re: Ann: Letter to Shareholders from the Boar... CB,
I guess what I am trying to point out is that Avexa already knows what they think and, even if they don't, predicting the answer is straight forward.
What they will say is the following, based on your current plans, you need to conduct a full (not a truncated) phase III study against 3TC and then a second study also against 3TC (this, by the way, is what Avexa has already been told by the FDA).
As I have said before, the FDA's job is not to find an indication or path to regulatory approval for a company's drug. It is to advise the company on what they need to do to gain approval for the indication they are seeking.
The point of all of that waffle being that you need to have a regulatory approval strategy first, before you approach the FDA. Then you will get meaningful feedback.
Avexa does not have that strategy yet.
Bob
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