Huh, that’s odd, it’s not like you to post reams upon reams of...

Huh, that’s odd, it’s not like you to post reams upon reams of bile and misinformation. A quick bit of assistance with your claims and some helpful suggestions before I head off to my New Years Eve gathering:

“That is precisely what the FDA recommended in the first CRL.”

For someone always harping on about the lack of visibility into the contents of any CRL I’m not sure how you can reconcile this point. The idea that we don’t have visibility into all of the details runs counter to the black and white proposition put here.

“SI said they would rather complain than do it.”

He didn’t, this is just silly. Maybe take a break and chat to a family member or friend in real life from time to time?

“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. “

Not like you to oversimplify and mislead. They did an incredible amount of work in this period as evidenced by progress made in the second BLA (the fact that its was actually accepted as an adequate and complete response, manufacturing inspection etc). Other posters have commented on this including the work done by Dr Kurtzberg over this period on biomarkers and potency.

“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.”

Context is important here of course. This was mentioned on a conference call as an expectation by SI. I think it’s fair to say that the company in its communications has always stressed independence of the agency and its actions. Most fair minded people would also judge that in the context of a large and complex review process, where the final outcome isn’t known until a verdict is rendered in the form of a CRL or otherwise, having an “expectation” about the next steps is an entirely reasonable thing.

“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.“

This really doesn’t hold up to scrutiny as we don’t know the contents of the CRL, it is also an reasonable expectation that the CRL contained comment from the agency on relationship between the proposed production assay and the the trail, where comment included comparison between the trial assay and the proposed production assay.

“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.”

CRLs list all known deficiencies with an application, moving on…

“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.”

Yeah ok, regardless of the source whether it be CRL or type A meeting minutes, we can be almost certain that MSB representatives did not buy some tea towels from K-Mart, strap an agency rep to a chair and torture these statements out of them. @Phaedrus recent post (the one you haven’t gotten around to responding to yet - lol) highlights how GVHD001 could well be considered adequate in this context.

“It isn't going to work.”

It will work, they are working through the issues step by step and the company will eventually receive approval for one or more of its therapies.

“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.”

There’s no arguing, it’s not an argument, it’s a process of agreeing next steps where deficiencies are identified. To follow the high school analogy, the teacher has really just asked for the finessing of some ideas in a final paragraph, within an already solid 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.”

Nah, they’ve been the best and fairest representation based on what the company has known at the time.

“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.”

Nah, they won’t, this is another silly false equivalency. MSBs studies have been better targeted at refractory treatment population. This point has been done to death already on the different types of SR-aGVHD (skin, gut etc).

Anyway, cope and seethe. Maybe you can get old Pockets back over here to give us a bit of flim flam every now and again. We all miss the old fruit.

Oh, and happy new year