fonda approval due july-oct-says rbs, page-8

G33,
okay for you I should have put the final part of the formal review process, pre-approval inspection, has been successfully completed in January.

How do I know this? It has been communicated to the market in several presentations by ACL, this is not news it is in the market.

However just to confirm this I have spoken to the company and they have assured me their presentations are correct, any questions arising from the inspections have been answered and they have not heard from the FDA for months. Not hearing from the FDA for such a long period is what makes Reddy's confident the approval is imminent, this they believe is one of the surer signs. That is their experience, they have passed this onto ACL.

So the formal review process has been ........ I will let you fill in the gaps. Maybe they have run out of Formally Approved stamps.