FDA approval should not be long now. Normally with a substantial base of original stability data - a product variation like the "in tube" will get approval with a limited base of new data (including accelerated - higher temperature challenge) and a commitment to continue the studies post marketing. Retained aged QC samples of "in tube" production would be available to support stability supplements to the QFT IT application. The FDA concerns are completely valid and it is probably lack of experience in these matters that these bases were not covered in the original application.
An "Approvable Letter" will be received within weeks of the stability supplement being filed if there are no further issues. The FDA will have been very helpful in trying to resolve this matter.
CST Price at posting:
0.0¢ Sentiment: Buy Disclosure: Held
