IF its 'SAFE' and TOLERABLE to dose, and it shows 'it can help', this is where it gets frustrating in terms of getting it approved.

 

  If the damn thing shows it can 'help' thru collected trial data, why not let it be 'used' (Tentatively approved) and let the PH 3 be a confirmatory trial that if it doesn't show enough to continue to allow it to be 'used', then cancel its 'tentative' approval. 

 

Cause they are now looking at another 2 years to get a potential decision date.