Ann: Submits New Information to FDA IND File for SR-aGVHD, page-271

That is a good link Reg, thank you.

Here is another - official-ish one -

https://www2.asx.com.au/about/regulation/rules-guidance-notes-and-waivers/asx-listing-rules-guidance-notes-and-waivers

that goes to Guidance Note 14 of the ASX on the ASX's Market Annoucements Platform



Whilst your article from Clayton Utz is good for putting things in an easy to read perspective - because its not from an official source - like the ASX there is a chance it could be out of date so I like to also be able to get to official sources where we can check stuff like the amendment history
and be confident we are up to date.



I found this comment interesting in the pdf because ...



.. sometimes I think company officials inadvertently break news to the market in forums that are essentially NOT in compliance with "Not releasing information that is for release to the market to anyone else unless and until it is has been given to ASX" - for instance I thought Dr Rose's statement in a webcast about problems with a potency assay was in this category - to the best of my knowledge such problems have never been stated to have existed by MSB in an official announcements - I don't say this to find fault with MSB in particular - I suspect a lot of companies inadvertent make disclosures sometimes that give hints to some investors that others wouldn't see the significance of.

Dr Rose's associating the word problem with potency assay was to me, in my opinion, market sensitive - because it helped me, I think, understand what had happened when I didn't previously.

@LearningEachDay replying to SapioStrategic 's question - why does the market seem to love it says in bold said -- "Because it shows we are continuing to move forward. We are, sadly, accustomed to delays so taking that possibility in stride. We know the end goal of approval and we see movement toward it."

LED, you've every right not to answer my questions if you don't want to but I'll ask you anyway as I'm interested in what you think.

1) Do you think that a BLA resubmission is still something MSB intends to do as a specific step "towards the end goal of approval"?

I do think that. I do think that the BLA resubmission still has to happen.

2) If the answer to 1 is yes, then Do you think the BLA resubmission date as a specific step to be taken towards the end goal of approval is actually closer now in terms of days then the market would have reasonably expected to be the case say two weeks before MSB's latest announcement? (What I'm getting at here is - are you taking news of a delay in effect, as being progress?)

I think the market would have expected we might have had a BLA resubmission within 2 weeks based on MSB's previous announcements two weeks before we got the announcement that we got.

Personally I don't currently expect that we will get a BLA resubmission announcement within 2 weeks. I acknowledge that we might - but I don't expect it. So personally I'm not seeing progress as having occurred as such.

Markets will form their own opinions, you and I will form our own opinions, but I can ask you for yours and you can chose to offer it or not.

Irrespective of what markets think - bureaucracies will follow procedures and laws for the most part (so there can be a comparative advantage to an investor to know those procedures and laws when others don't) and what is scientifically possible will also constrain what gets done (and many market participants won't understand the relevant science) - so I think its possible by understanding either the procedures and the laws bureaucracies operate under or the relevant science to make better guesses than the market by better handling the information available then does the market.