No one really knows at this stage if they did or did not file it during January ? As I pointed out the other day from the 2 January 2020 announcement, it clearly states “the FDA acknowledges receipt of XXX” ... it is my belief that the final part of the BLA submission has been lodged and we will be told once the FDA actually acknowledges receipt again this time? ........ and/or they may even wait to see if Fast Tracking / Priority Review is granted and then announce that to the market, which subsequently would confirm (obviously) that it had previously been submitted in January ?
Before we get out the pitchforks, let’s just see what transpires over the next week or so !
I also believe that given this treatment now has the word ‘cure’ associated with it and mortality rates are high in children suffering aGVHD along with the fact that we are actually talking about a Pediatric treatment, that the FDA will move swiftly on it ? I wouldn’t even be surprised if the first submission had been thoroughly checked before the next piece even left MSB ?
These are my opinions / beliefs so don’t go rushing out and buying shares based on the content in this post - just sayin’
GLTAH
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