Hi @ddwn,Good point, it was part of the submission papers back...

Hi @ddwn,
Good point, it was part of the submission papers back then. I believe that Novartis having a pretty poor alternative in the adult market for srGvHD has added to the supposition on HC, that the letter was written on their behalf despite that they don’t I believe have the rights in the USA.

When REM-L is approved this year (IMO) it will only be a matter of time before it is approved for all ages. It is so superior a therapy.

As to who was behind the legal letter, we won’t I expect find out. They cost buttons to send and if I had been shorting at the time or had a product that could be sold to those over 12-18 where the overlap was, and it being a superior therapy, then it would make sense. I am told that these letters are not uncommon for all sorts of reasons I expect but it being behind the FDA decision? To big a leap I believe.

We know that the management in the FDA responsible for the initial decision changed at a crucial time. We know from Mesoblast (I am going to accept SI’s comment ) that they did what was asked ie were working on a single arm basis based on precedent and with the agreement of previous FDA management).

Mesoblast and the kids needing the approval were unlucky to get a poor decision. IMO an indefensible decision.

The FDA top people are changing this month, the appeal process is underway, it will take a few months probably and at that time all the previous correspondence and minutes from any meeting will be relevant. This letter is immaterial to that.

While the normal decent individual (all of us for example) would be shocked at how callous motives can be behind letters such as this one, I’m afraid there will be much worse out there.
regards
Yelrom