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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-311

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ddwn

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27/03/24

11:14

Post #: 73079470
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Originally posted by JB1975: ↑

I took a look at a grainger post with, as of yesterday 34 ticks (if you want to find it) that provides a link to a video from around 2 weeks ago with Silviu speaking at ********* or something like that.

Because the announcements have tended to confirm my analysis over recent years (insofar as they give detail) and because I don't short I don't directly profit from analysing MSB (I do it out of interest in the field and in medicines that goes back a long way for me) I tend not to watch the cafe style stuff and some of the webinars like the committed holders that comment here do - but when I do I find (and this is not necessarily a good thing - I could be prone to confirmation bias as well) that the further investigation just tends to reinforce my impression. But my impression is based on thorough research years ago and just keeping sort of up to date since CRL 2.

If you take a look at the ********* stuff grainger provided, in my opinion, its looks like Silviu and co have pulled a big switcheroo with this announcement - they weren't going to the FDA about clinical trial data mainly they were going about potency assays - and they were going to get feedback by the end of the month of march. So I think they've got feedback. And I think they've reported the positives they could take out of that feedback. Butt they aren't saying the FDA is okay with their potency assay approach - the closest they get to potency assay is to talk of product characterization (which includes potency assaying) but is broader than that.

I think if you take an impartial look at what Silviu was saying in that ********* video (its about 14minutes) with an eye to what they were going to ask for, what they saw as being important and so what they were anticipating reporting back to the market about by end of march, I think you'll see that what they have reported back to market with so far in march is not the same stuff they considered to be important even back then.

I'm seeing a sort of switcheroo having been pulled - analogy - patient in hospital gets good news and bad news - sorry you've got terminal cancer and six months but there is a special on blueberry muffins from the tuck shop right next to the hospital - SI then cheerfully reports on the cheap blueberry muffins.

Take a look at the video linked in graingers post (if you want - this is a suggestion only obviously to you and anyone else interested) - see if you see things like me after that, or if you think I'm just interpreting what has happened in a bias way.

Expand

Just step back a bit and think this from a broader perspective...

What you are saying is that SI and Mesoblast have provided us with some shenanigans.
Now, that may make some sense if they are trying to pump up the SP for an upcoming CR - but, the CR has been done and we are now cashed up.

Why would SI and Mesoblast be so stupid to shoot themselves in the foot with all the ambulance chasers running around?
As if you are right, this shenanigans will be revealed shortly!
It doesn't make sense to me...

But, the alternative makes sense - i.e. what the public company announcement has stated.
The FDA have ticked off the CRL items, and have cleared the pathway for Mesoblast to resubmit the Ryoncil BLA.
Of course, with any BLA - approval is not a given and hence they have to qualify this announcement with lawyer's wordings

What say you @JB1975?

MSB Price at posting: 55.5¢ Sentiment: Buy Disclosure: Held
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