fonda approval due july-oct-says rbs, page-5

Tower44, where does the information that "the formal approval process was successfully completed in January" come from? Maybe you mean the FDA inspections in India were completed?

I don't think the act of inspection would, by any measure, mark the end of the process.

The FDA inspectors would then go back to the US, write a report, that report would go into the bottom of their next-up's stack for review, then on to their next-up ad infinitum, and who knows what other internal admin processes would go on in the FDA.

I'd imagined that once the file gets the big red FDA "APPROVED" stamp on it, the FDA won't have any reason or wish to sit on the application any longer.

Therefore, IMHO it clearly hasn't been "formally" approved yet.

Like you, I took on board page 4 of the last presentation and have no reason not to believe June isn't the month for approval ...... apart, dare I say it, from ACL's poor predictive track record so far!