Subpart E does not mean subscientific, or substandars.
The logic of subpart E is that a "surrogate benefit" that is known to be a factor in the final expected outcome could be the basis for approval of a drug.
simple example: If drug A is able to disolve clots and disolving clots is clearly good to save a limb, then one could MAYBE considered just disolving the clots as a basis for approval... of drug A...
... Catch 22 is that surrogate factor MUST BE PROVEN epidemiologically and that is rare on itself and difficult on itself , in the case of xoma neuprex for meningo NO SURROGATE FACTOR is identified clearly as a PROVEN PREDICTOR of less mortality or less morbidity.
The one and only statistically significant point in the study was POPC at day 60 (p = 0.019) and this is NOT a proven predictor of anything, more if one gets the data for day 30, or 45 or 75 what is the p =? to? why not showed that data, were it probably is or not as striking as the shown one. Even if all of those days are, still is not a proven predictor of anything yet, the POPC came from where?
where was it validated? where is the clear predictor:
NO WHERE!
So, Mr Blue and Green, Subpart E is not your dream dump it there in the recycle bin and we will get a sure by product, is an stringent albeit flexible tool for real proven facts, not Si board imagination concoctions. |
