Hypoglycemia and the FDA?

[goyocafe]

So if I understand this at all, the FDA will allow incidents of hypoglycemia to be included as an important factor when looking at adverse events and significant adverse events, but when it comes to allowing it as an important aspect of the medical benefit provided by a novel treatment, it suddently becomes a subjective, difficult to measure issue that they are not in a position to evaluate. Talk about having your cake and eating it too.
Did anyone else get this from the FDA guy that answered that question just before lunch?

[StevieRay]

Apr 1, 2014 11:59:16 GMT -5 goyocafe said:

So if I understand this at all, the FDA will allow incidents of hypoglycemia to be included as an important factor when looking at adverse events and significant adverse events, but when it comes to allowing it as an important aspect of the medical benefit provided by a novel treatment, it suddently becomes a subjective, difficult to measure issue that they are not in a position to evaluate. Talk about having your cake and eating it too.
Did anyone else get this from the FDA guy that answered that question just before lunch?

This is a great point and it shows just how biased against Afrezza they are!  I hope this comes out in the discussion later today!

[alcc]

I know. Imo the FDA looked silly. Whereas the high dropout is a legitimate concern, what effect that has on the primary end point is pure speculation based on which statistical model you pick. Yet they put huge weight on this "missing data". And then turn around and dismiss real data points on hypos. Jokers.