Anavex Life Sciences Corp (AVXL)

[skitahoe]

Many of the delay's I've seen from the FDA have revolved around commercial manufacturing and shelf life of the product. In the UK, and apparently the rest of Europe they approve the the commercial manufacturing facility before a submission is made for approval. Applying to the FDA before the manufacturing facility is complete may save time as the inspection can come months after the submission, but inspections often require changes and reinspection's which often delay approval. The fact that the European inspectors approve a facility doesn't guarantee that the FDA will accept it without any changes.

Some companies invest in commercial equipment, or contract with CDMO's for commercial quality material for running the Phase 3 trial. If that's the case it certainly lowers the burden in filing for approval. I know nothing about what AVLX has done to prepare for commercial production anyone's welcome to fill me in.

Gary