Grapefruit USA Inc (GPFT)

[BuyOnDips]

Quote

I feel as though w/ the new set of reviewers and the FDA's "fast track" the DVIS is being completely re-evaluated by the FDA.

Could that be the reason as to why we on the way to a full 90 day review cycle?

Does anyone with knowledge about this process know?

I feel that they re-configured or re-submitted the DVIS and just didn't tell investors the complete story. End Quote

I agree with your first statement that the reviewers are doing a 100% review and not relying on past information from the previous administration.

I think in most cases they use 90 days or more. They report their own numbers, they have no over site so this number is whatever they say it is? We have gone over the 90 day mark in the past so this is no surprise to me now.

I don't think the Dominion has been reconfigured IMO. They removed 2 uses and Dean stated they would re-apply for those on separate 510Ks.

I do think that the Radiology Review was a stop gap measure agreement between the FDA and IMGG to possibly avoid the PMA route. Again My own opinion.

Yes I'm sure there are things we dont know as shareholders. But Dean Jane's has been very forthright with information to shareholders to date. At times may be to much! Overall I feel he has done a great job. We all learn something each day.