Posted On: 10/04/2013 7:28:48 AM
Post# of 5066
I made my initial request, via written submission, to the FDA on or about 03 September 2013. Eight days later I believe it was, I received a phone call from the chief lawyer of the of the FOI division at which time we had an in depth conversation about my request and the protocol. Since I know how the system works, I knew my request would be denied. However, the point was to provide proof that there indeed exists an IND application for HemaXellerate, the amount of time it will take to process a denial (to shed a little light on the amount of time one should expect for them to process an application for human trials) and that whenever the denial is received, credence to the fact that it is still under review (i.e. NOT DENIED) , exists.
The total processing time for the denial from start to finish was 27 days. The letter is dated 30 September with the envelope being postmarked on 1 October. I am a stones throw from DC/Rockville area compared to most on here. The post was delivered to me yesterday, 03 October.
My disdain for the CEO's actions and inaction remain the same. However, as I have tried to convey a multitude of times, there should be no doubt that the HemaXellerate IND process is very much underway and has had many a challenges, including the Oregon State mishap (no fault of the doctors or reflection on the treatment itself. But, yes, one can argue a failure on the part of the CEO), the trademark name mishap (no fault of the doctors or reflection on the treatment. But, yes, one can argue a failure on the part of the CEO), the medical issues suffered by patients in similar studies that are in no way associated with HemaXellerate that have caused the FDA to see fit to request further preclinical studies and now the gubment shutdown, to name a few.
I guess I will go post this elsewhere. Maybe they will find this as being on topic and see fit to sticky it for those who have yet to make their way here. I doubt it though.
The total processing time for the denial from start to finish was 27 days. The letter is dated 30 September with the envelope being postmarked on 1 October. I am a stones throw from DC/Rockville area compared to most on here. The post was delivered to me yesterday, 03 October.
My disdain for the CEO's actions and inaction remain the same. However, as I have tried to convey a multitude of times, there should be no doubt that the HemaXellerate IND process is very much underway and has had many a challenges, including the Oregon State mishap (no fault of the doctors or reflection on the treatment itself. But, yes, one can argue a failure on the part of the CEO), the trademark name mishap (no fault of the doctors or reflection on the treatment. But, yes, one can argue a failure on the part of the CEO), the medical issues suffered by patients in similar studies that are in no way associated with HemaXellerate that have caused the FDA to see fit to request further preclinical studies and now the gubment shutdown, to name a few.
I guess I will go post this elsewhere. Maybe they will find this as being on topic and see fit to sticky it for those who have yet to make their way here. I doubt it though.
(0)
(0)Scroll down for more posts ▼
