Post by
DryBones on Aug 03, 2015 3:52pm
odds unpredictable
Neither acceptance of filing, fast track approval, or rejection of orphan status has any bearing on whether we get our license.
Comment by
tater1 on Aug 03, 2015 6:01pm
True we don't need orphan status, priority review would be nice, but not having our submission accepted would be disastrous. How could it be otherwise?
Comment by
DryBones on Aug 03, 2015 6:48pm
- not having a submission accepted wouldn't be disasterous. It would simply mean some element of the data package was missing. It could be corrected. However, gettting the filing acccepted means only that it gets reviewed; It doesn't increase the final odds. However, the market wil interpret these events whatever way it wants.
Comment by
tater1 on Aug 03, 2015 8:08pm
We hope it could be corrected. But if they are not receptive to our BLA filing we can't get to the review. First things first, approval is the most important event at this time.
Comment by
princeofcut on Aug 04, 2015 11:27am
tater1, you are correct arthierrrr is a bagholder you should only use him for laughs..not receiving an RTF will be very positive for TST IMO.