RE: RE: RE: ZZZZZZZZZZZ.....They have to submit New drug application ( NDA )when everything is ready as follows :
The documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug formulation are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. Once approval of an NDA is obtained, the new drug can be legally marketed starting that day in the U.S.
Once the application is submitted the FDA will decide if it will get a standard or accelerated review. A standard review implies an FDA decision within about 9 months.
A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.
-----------------------------------------
so they submit NDA in October, it will take 6 months to get approved. That means in March next year.