MESOBLAST LIMITED (ASX:MSB) - FY22 - It's all to play for here!, page-35 - HotCopper | ASX Share Prices, Stock Market & Share Trading Forum

Originally posted by dachopper: ↑

Finally I managed to listen to the full webcast and Q & A, some good hidden Gems in the commentary .

Analyst... It appears as though the fate of GvHD and Covid ARDS is intertwined, would it be fair to say you are heading for an inflection point with potential GvHD and COVID EUA shortly..... MSB - Thank you for that comment, and yes we feel exactly the same.

BP Analyst - According to the Novartis agreement, they will fund the all cause ARDS trial, does that mean Mesoblast will be fully funding the COVID ARDS EUA trial...... MSB - It's too early to say, all options are on the table. ( probably meaning there is an option for MSB fund, or to get novartis to fund )

Analyst - Are you looking to use the biomarker data gathered during the covid trial, and will you be sharing this info with the FDA....... MSB - we gathered a very large amount of biomarker data results, and we look forward to UPDATING THE MARKET ONCE WE HAVE FINISHED ANALYSING THE DATA. Our understanding of the disease and of the role in biomarkers has progressed significantly over the last 12 months, and what we are looking for in the analysis is the pattern of Biomarker levels that represent Remestemcel having an impact through the theoretical mechanism of action. As we continue to analyse and gather more data, we gather more evidence that supports the mechanism of action in vivo to compliment the in vitro assays to support the MOA. Proving the MOA is not required for product approval, only supporting the MOA through the use of manufacturing assays and obviously efficacy.

So Sorepockets............. why on earth would Novartis still be analysing the data...... well the answer is because Mesoblast have not finished analysing it - which means it is not released to Novartis. Once Mesoblast finishes analysing the data it gets released to Novartis to analyse..... and as was repeated YET AGAIN in this FY update the closing conditions include time for Novartis to analyse the data. Looks like they haven't gone anywhere.

The Share price is going to get a real shock next quarter when everything the company has been working so patiently on finally starts to come to fruition.

SI sounded very bullish on the FDA meeting they just had saying that MSB knows the path of exactly what it needs to do, and that the FDA were very helpful ( This is in contrast to the last one where immediately following it he said it appears the FDA will not agree to approval ). He also stated MSB WILL get full agreement from the FDA on potency assays prior to commencing the next trial, and that there is a huge push coming from the FDA to get this done ASAP given the unmet need and the EUA they are going to get if the results are good. Remember they started the last trial within about 3 months of the initial emergency treatment group. They have over 20 million USD of product sitting on the shelves right now that could be used for trial purposes if needed.

There will also be a Crohns update in Q4, and MSB unusually said they would update the market once they have finished analysing the biomarker data...... So I would assume that any Novartis announcement is going to occur After this point, as they probably haven't even seen the data themselves at this stage.

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Thank you for breaking down all the import information from the Webcast dachopper. I admire your passion for this company and your constant positive but realistic insight into what's on the horizon for Mesoblast's future. Very valuable contributions you share, much appreciated

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(20min delay)
Last $1.01		Change 0.030(3.06%)		Mkt cap ! $1.153B

Open	High	Low	Value	Volume
$1.01	$1.04	99.0¢	$5.111M	5.050M

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