Posted On: 10/06/2013 5:15:23 PM
Post# of 5066
Hi New4This! Glad you made it. 
You are correct in that when trials are finally approved for Hema, you should be able to find the info listed at the clinicaltrials.gov site. However, it is hard to say when we will find Hema included there. As I mentioned last week, the NIH had halted all new studies during this shutdown. But, I have since been told that rather than being halted right now, new trials are being logged but at a very slow pace. Of course, these are for trials that have already completed the IND process. And most likely had done so well before the shutdown.
IND applications are still being considered due to the funding by the applicant's covering the costs for the applications although new applications are not being accepted presently (something to do with appropriations legislation). However, the FDA have to triage and are working with roughly half the usual number of employees. This will have a significant impact on a large number of cases the FDA has which means don't expect anything in the IND department to happen anytime soon so long as we are in a shutdown.
So, it is safe to say that Hema is being delayed, once again, through no fault of the doctors or the medicine. I have no idea how long the delay stands to be or whether the latest data can/will be accepted immediately if completed and subsequently forwarded to the FDA after the shutdown began (listen not to anyone that says the additional requested data is tantamount to a denial. That just isn't true).
I'll try to update you with what I learn about the FDA operations/shutdown details as I can.
You are correct in that when trials are finally approved for Hema, you should be able to find the info listed at the clinicaltrials.gov site. However, it is hard to say when we will find Hema included there. As I mentioned last week, the NIH had halted all new studies during this shutdown. But, I have since been told that rather than being halted right now, new trials are being logged but at a very slow pace. Of course, these are for trials that have already completed the IND process. And most likely had done so well before the shutdown.
IND applications are still being considered due to the funding by the applicant's covering the costs for the applications although new applications are not being accepted presently (something to do with appropriations legislation). However, the FDA have to triage and are working with roughly half the usual number of employees. This will have a significant impact on a large number of cases the FDA has which means don't expect anything in the IND department to happen anytime soon so long as we are in a shutdown.
So, it is safe to say that Hema is being delayed, once again, through no fault of the doctors or the medicine. I have no idea how long the delay stands to be or whether the latest data can/will be accepted immediately if completed and subsequently forwarded to the FDA after the shutdown began (listen not to anyone that says the additional requested data is tantamount to a denial. That just isn't true).
I'll try to update you with what I learn about the FDA operations/shutdown details as I can.
(0)
(0)
