I don't want to confuse anything, or stir up any issues, or look like a moron... but if I am understanding the PR yesterday, all it said was we were given a number... next, we are waiting for FDA to give BMSN the green light to start the trials...
It is also my understanding that we would file for Orphan Drug Status AFTER we get the go ahead for the trials??
So.. if I am correct, here's what I see...
A. within 1-2 weeks FDA approval to start trials... PR Released
B. a week after that, BMSN files for Orphan Drug Status... PR Release
C. BMSN lays out plans for trials, where, how, who, etc.. PR Released
D. BMSN is granted Orphan Drug Status... PR Released
D. BMSN announces how they are funding the trials, and what the time frame is.... PR Released
Although my order may not be correct, these are things that still need to happen.... So, it would seem to me that even before we actually get started with the trials, there would be several PRs released...
Can someone help me out here? Am I understanding (BASICALLY) the process here?
-Michele