no good reason > than 30 days.
Dewm - I Don't understand your post. You lay everything out like you also understood and accept my opinion, but then you go right back to head in sand mode with the final statement:
"As I indicated before, the FDA drilled this to the nth degree already and there is no good reason for it to take any longer than 30 days. Biel is not making any changes to the device, they are just showing a clinical trial for back pain to expand the approval into full body muscle and pain."
The reason there is a "177 day average" is because there is a line.
The FDA doesn't have unlimited resources.
It would appear that their metrics have been accepted with that "about 6 months" mark for standard filings.
IF YOU WANT TO CUT IN LINE... then you can file for EAP. In which case, you would get a priority review.
IF YOU DON'T QUALIFY FOR EAP.... guess what. Line.
A meeting is a meeting and guidance is guidance. I've been in plenty of meetings like that. They (FDA) are usually in a room full of "witnesses" are very careful not to make promises or commitments to the company seeking information. They will direct you to the processes and the forms which may or may not be applicable to your situation, depending on many things. IF THIS, THEN THAT, MAYBE - DEPENDS - SUBMIT FOR REVIEW.
Bottom line is.... line.
But really, someone could call BIEL and clarify what THEY expect in terms of days until clearance. Mention BIELs own averages for clearance thus far. Mention industry averages.
Ask if it is REALISTIC to expect clearance "within 30 days" (LOL). Why would FDA even have EAP if all you need to do is know someone or be familiar with the product already? pfft, not how FDA works IMO -- it's all transparent. That's why Emergo group was able to compile their data for the report on filing times.
