copying this from alonzer's earlier post;
First company EVER to receive orphan (both US and Europe), QIDP, priority review, fast track and now breakthrough designation." as one of our posters here pointed out well. So the FDA has been moving this forward...Will said FDA "is a good partner". Good relationship, helping it move along,
Hi Mike, I thought that may indeed be the case, but really had no idea how to research it. Either way, whether or not they are the only company to receive all of those FDA designations or not, it certainly does show pretty clearly that the regulators seem to be in their corner!!
Clearly, major pharmas are keenly aware of all these designations and are knocking on the door. The only question I have is: how high will they bid? $40,50,60....more? I see a $3-5 billion company in a few short years if they stay intact. Will they?