Replies to post #1345 on GG&G

[uksausage]

I do not believe there is an application to get clearance for a wider use so how can the FDA give it clearance?

It was my understanding BIEL would have to "reapply" with the back pain study results OR may be the change of FDA rules to allow Real world data might trigger an internal review since that has already been submitted.

I haven't seen when the final decision and enactment of real world data rule change is happening

Hopefully he will clear this up as well as the current retail launch this week

[JustGarden2]

2Relax, the question should be, did they ever submit the data from Oxford University that was needed by the FDA in order to review for approval. The trial data was suppose to be available in March. Have seen no evidence that it was presented.