Paul's comment.....
"The reason we expect an answer from the FDA soon is predicated on the discussions at the meeting. The reason we did not get resolution at the prior meeting is that the FDA came up with a subsequent issue. We think, now that we understand their issue, and we have provided an adequate explanation."
What and when was the "prior meeting" could be critical. Could it be that this was the second meeting with FDA since the rejection on ALLAY? Or, does it mean there have indeed been 2 meetings, but one before the rejection and this last one, meaning perhaps that the rejection was because FDA came up with a subsequent issue after the first meeting which was after the rejection.
If one looks very carefully, FDA and BIEL had a meeting. FDA came up with a "subsequent issue" and then rejected ALLAY? Makes no sense. If they had come up with a subsequent issue, FDA would have asked for more info/answers before rejecting. I say there was the rejection, then there have been 2 meetings since the rejection....BIEL did not get resolution at the prior meeting AFTER the rejection and FDA asked for this last meeting to get clarification for that subsequent issue, which they did on Friday, and that is why BIEL now expects a positive answer "soon" - because the answers to the "subsequent issue have been provided to the FDA's satisfaction.
And that may be why the invention of the difference in tissue to separate ALLAY and ActiPatch. C'mon, the FDA has a plethora of data now on both products. This also seems to me to be the very necessary diplomatic camouflage for,
"Let's see, how do we find a way for everyone, FDA & BIEL alike, to save face? Aha make it a double face saver - subsequent issue and tissue difference - wonderful, that should do it."
Never forget fellow investors, we are dealing with humans and when humans err we all need a way to save face rather than having bashers pounding people into the ground in a demeaning fashion and detroying their dignity. I like it! The shorts may not, but I do!
