Quote:
Originally Posted by Tupelo3
This trial, conceptually, is somewhat similar to the Isradipine Steady-PD trial. In that study the FDA required a 1 year phase 2 (which was successfully completed). The phase 3 commenced the end of 2014/ beginning of 2015 and is designed as a 3 year trial. If the FDA required a similar timeline, and taking into account time for patient recruitment, data analysis, NDA submittal and FDA review, you would have a minimum of 6 years. Of course, there is interim monitoring and if the results warranted it, the trial could be stopped earlier.
|
Seems like a long time to extend testing on already approved drugs if trials are positive. In the case of Nilotinib doses are much lower for PD patients. Not sure what hoops have to be jumped through to fast tract these approved drugs. First at least in the case of Nilotinib we have to wait for official published results and hope they compare to the unofficial results I was told. And I agree with ST that a lot can go wrong especially, in this case , the funding. STill I'm staying upbeat about this drug. I have to believe something out there is going to work for us to keep me going.
All the best to everyone.