Pat;here is alternative view if you like. By simply stating that...

Pat;

here is alternative view if you like.

By simply stating that the fda "returned the submission with a request for additional data", simply says to me that the submission was made without consultation with the fda as to what data and how much of it will be required. If this is the case, which to me it sounds like it, then this is a critical fault on behalf of Throatec. They should have had that pre-determined BEFORE the submission.

This is not the case with vcr!!!...the approval for both BTT and DT protocoles has been given with a clearly defined exit criteria for vcr.

This is one things that "techos" do, and they do well, which is the case of the board that's running vcr. Which, again, is unfortunate, since they need to balance that with an entrepenrial flare. Too much of one thing is not good in any case.

Cheers