Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-36

Its not even clear whether MSB have been told a date and aren't disclosing it, or if they haven't been told themselves.

I suppose the company could be asked - did the FDA give you an actual date - but experience suggests that won't actually happen either.

Even the 2nd of August is being referred to as a "goal date". Which is technically true - the FDA is KPIed against numbers of BLA and resubmitted BLA's that it completes within the timeframes - but they don't usually get 100% of them.

In my opinion either MSB is treating the market like mushrooms or the FDA is treating MSB like mushrooms. Neither should be acceptable - security and safety concerns - like FDA site inspectors are being kidnapped and held to ransom by agents of those shorters on such a regular basis that its not even news worthy anymore.

"we look forward to continuing to work closely with the FDA during the review period".

Yeah and I look forward to continuing to work closely with Hayley's comet which ts scheduled to turn up again sooner or later as well.