LeftYahoo.. your comments are always logical and...

LeftYahoo.. your comments are always logical and considered.
Based on your detailed analysis that from day one MSB's P3 open label trial should never have occurred because it was not RCT.

Request:
Similar to your recent explanations, can you please provide a logical explanation, as to why back in 2015 , the FDA approved the 55 patient open label trial, if it was never going to work and they always would have required a RCT ?

Could the FDA mis-communicated (were not clear) given its an Orphan Drug/ Unmet need.. or alternatively did they change the goal posts ?
A lot of good money was spent on treating the 55 patients ..

• what were the expectations of the FDA after the 55 patient trial was completed
• If the FDA knew from the start open label would not get up .. why accept the initial BLA and then spend more spend valuable funds on an Adcom

If there is a logical answer here, it would help ne understand your position with SI.

Otherwise .. there is two sides to the story .. and unfortunately as this stage .. we dont know either side

(for the record .. very pleased for the patients that were involved with the trial and particularly with the 4 year data).

GLTAH's