'IMHO I think it is responsible management to speak with the FDA...

'IMHO I think it is responsible management to speak with the FDA regarding end points etc before lodging,'

Jatter, I'm not sure this is being understood. For an IDE it is about approval to run a very small trial to prove the efficacy, and to determine if the benefit outweighs the risks. I'm not sure what end points can be discussed at this stage? In any case I thought they had lodged the application for an IDE?

The FDA, assuming it is not rejected, will state how many pts can be recruited and at what centre(s). Then they have to form on IRB and obtain approval, although this should have been started well before now. Then they have to recruit and this can be painfully slow. Some time after the last recruitment is performed, then the wait starts to determine the effect of the treatment. Once it can be shown that the is a benefit to pts, then they will go back to the FDA for the next approval. This could be 2 be 3 years down the track.

The granting of approval for on IDE, is unlikely in itself to impact the SP for anything other than a short term blip.