MESOBLAST LIMITED (ASX:MSB) - MSB 2023 - awaiting for Ryoncil approval, 65519882, page-121 - HotCopper | ASX Share Prices, Stock Market & Share Trading Forum

Originally posted by dachopper: ↑

Given that the potency data addressing the CRL was deemed price sensitive then one could surmise that any FDA feedback would also be price sensitive?
I don't think so, I've seen other MSB releases that I thought surely must be price sensitive, and the only conclusion I could draw was the ASX thought that unless it is related directly to approval then it probably isn't. Ie.... FDA say MSB submit it we think we will approve ( which they will never say of course ). Accepting the BLA resubmission for example, in no way guarantees anything, so how could it be price sensitive? If it were rejected on the other hand I think that would be price sensitive.

With one shot at the BLA resubmission, I’m thinking we would get a price sensitive announcement as to whether the new data has addressed questions raised in the CRL.
Then, if positive news, another follow up announcement on the BLA
resubmission.
.... MSB has allready said they will address all items in the CRL, and then the FDA accept the BLA, that is them accepting that MSB have addressed all items in the CRL. Again, I don't think any of it is price sensitive.

I think we will get these announcements :

Back pain trial is approved
BLA is lodged
BLA has been rejected or PDUFA date has been confirmed
CHF feedback on next type of trial design
BAbababababababa back pain trial has commenced
Ryoncil is approved
Ryoncil is commercialized
CHF is partnered
GvHD Adult trial is commenced
ARDS trial is approved
Babaababa back pain has passed it's 1st, 2nd, 3rd futlility study
ARDS trial commences
Back pain achieves primary end point
Mesoblast Parntners for Back pain
CHF trial commences
Back pain commercialized
Crohns phase 3 trial commences
Sepsis phase 2 trial announced
GVHD adult trial passes futility 1/2/3
GVHD expanded to adults
ARDS trial passes futility 1/2
ARDS trial halted due extreme efficacy at 3rd look.
ARDS approved
Sepsis Phase 2 trial commences
Crohns phase 3 trial completes
CHF passes futility 1/2/3, halted at 3 due extreme efficacy
CHF achieved primary end point
CHF approved
Sepsis moves into phase 3
Sorry I got a bit carried away there planning my future.

Anything else will be fluffy like FDA reviewed the IND file update and we followed their direction and resubmitted the BLA.
Just like I believe the company said they updated the IND file in accordance with FDA direction ( paraphrased )

IFF I’m right - and it’s quite plausible, my opinion- then on positive potency data news the share price will rocket .
Well, I don't think that MSB are going to give you that specific warm and fuzzy in their announcement. This share price has been absolutely put through the toilet. I expect just prior to PDUFA ( assuming they get that far ), the price will be no where near 87 cents. It was over $5 last time.

Expand

MSB has allready said they will address all items in the CRL, and then the FDA accept the BLA, that is them accepting that MSB have addressed all items in the CRL. Again, I don't think any of it is price sensitive

Thanks for the reply Dachopper - always good to get another’s opinion.

I just find it interesting that Meso is dealing with CRL items directly with the FDA prior to BLA resubmission.

Krause at work I presume.

Price sensitive- my belief is that a reasonable person would assume that BLA resubmission meant the company was confident of acceptance/approval - which would have a material affect on the share price.

Who knows when ….. maybe today

Loved your timeline

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Last $1.03		Change -0.040(3.76%)		Mkt cap ! $1.170B

Open	High	Low	Value	Volume
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Last $1.03		Change -0.040 ( 3.65 %)
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Last updated 15.59pm 06/06/2024 ?

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