Hey Arizzle
Seems to me that all 57Chevy said is correct and so are you in that it didn't address your question of REDZONE's post as to the basis of his statement about July FDA approval.
To color it a little more, I believe there was information published by the FDA wherein they generally forecasted a period of 60 or 90 days (can't recall which) to process applications and reach a decision, as part of an expedited application processing timetable for the future. Was this well thought out and realistic, or just wishful thinking to placate one's masters? Who knows, but it is dangerous ground to estimate one thing and rarely, if ever, deliver. One of the most costly aberrations in industry and government in our country is the lack of realistic estimates, from budgets to promises of delivery. I regularly advise people submitting items to me to please tell me the truth; don't tell me what you think I may want to hear because it corrupts the decision-making process. I, and thousands of other decision makers constantly fight against the natural human tendency to gild the lily.
I prefer to deal with facts and logic when speculating (and I regularly screw that up!):
Is there activity within BIEL related to the proposed new device classification by the FDA? You bet there is. Has to be.
If so, does it concern assembling trial and other data for a new, or amended, 510K application? Yup
Has Whelan learned from the first FDA fiasco and become wiser and more humble? One fervently hopes so.
Will he assume a more appropriate CEO role and allow his expert team to make this happen? Same answer as above.
Any timing estimate right now is pure speculation. I think that answers your question, but it's sometimes fun to ponder such things, no?
