Ann: Update on Institutional Placement and Entitlement Offer, page-351

"where does it say that the adult trial has to be completed for the pediatric GVHD to be approved?"

That is precisely what the FDA recommended in the first CRL. SI said they would rather complain than do it. The company told investors it was really 'just a problem with the potency assay' and after a couple of years they had a "validated" potency assay and resubmitted the BLA. SI told investors that the only outstanding thing was "a discussion on the specifics of the labelling". He was clearly not on the same wavelength as the FDA again.

Instead we get some weasel worded announcement that the FDA "acknowledged that the potency assay had been improved". The word "acknowledged" is interesting. It indicates some kind of response to a question from the company. It wasn't a spontaneous statement from the FDA. They also didn't say the treatment is efficacious in the second CRL. The company started making statements that if the FDA didn't say it WASN'T efficacious then the FDA obviously accepted that it was. Which isn't necessarily true. It simply wasn't addressed.

Now we are getting other weasel worded statements about how the FDA "acknowledged twice... that it was an adequate and well conducted trial". Once again the FDA didn't spontaneously make that comment. It was some sort of a response to a phrase used by MSB representatives. It looks like they are playing word games to try and and trap the teacher into giving a "pass" to an essay that's been marked as a "fail", and at the same time give investors some false hope to hang on to to support the company's approach and the share price.

It isn't going to work. The endless arguing about the CRL isn't going to change the outcome. The teacher said the essay is fundamentally flawed, please go away and do it again properly in accordance with the clear instructions. Now SI says they were always going to do it but he still wants to go on arguing about the second "fail" mark for the resubmitted essay.

The company's statements have been repeatedly wrong and misleading, from timelines to expectations of trial results to partnerships. I can't think of a single time SI has said something that turned out to be accurate, with the exception of the BoD's remuneration.

And yet despite being sued for misleading investors, they still accept his words as gold.
The FDA is going to say, well Osiris did randomised controlled clinical trials, so can you. Stop making excuses, that's what we want.