RE:RE:RE:RE:RE:BTD is slow process. stocksnbonds458 wrote: Agreed patience. From what I understand it's just a matter of retrieving information and data from the study sites that is already existing, they are not requesting new data to be extrapolated . The process of requesting this information is soooo textbook bureaucracy.
First they must:
1. Submit a request to the Study Coordinator at each Site to receive approval from the patients to allow the release of information.
2. Once that is in place, they then must submit a request to the Coordinators for the data that the FDA has identified to TLT.
3. The Coordinators have to assemble this data and send it to TLT, where then TLT will prepare and submit the updated Pre-BTD letter to the FDA.
TLT began this process in August, shortly after the request by the FDA for more information. As far as I know we are still somewhere in between variations of numbers 1, 2, and 3 above. Hopefully after pre-BTD is okayed, then they should be in a position to submit a formal BTD application. IMO, if the FDA approves the pre-BTD, then receiving the actual BTD should be almost certain. In other words, if we get pre-BTD approval by May, then it's time to fire the rockets!!!
They just keep pushing it down & down. I just keep picking up more & more.