I have done an awful lot of reading the past sever
Post# of 5066
I have done an awful lot of reading the past several weeks and truly believe there are two patient specific drugs treating disorders or failure of bone marrow being created/tested, i.e., Hemexellerate therapy 1 & 2. If I am correct, treatment of failure is dependent upon treatment of disorders. proving efficacy is key at this stage of the game. IMHO, if they have failed at providing this evidence to the FDA, such would have been divulged at this point since it would not be a simple matter providing additional information to the FDA. The process would basically have to start from scratch. I think the delay of PR is a result of finalizing what further info was required by the FDA. Politics has a lot to do with the scrutiny at this point. Therefore, the FDA is moving at a snails pace. Again, IMHO, positive PR is forthcoming.