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MSB Trading 2021 - paradigm shift, page-8475

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Lopez

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27/10/21

13:45

Post #: 57113424
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Originally posted by stockrock: ↑

After a seemingly quiet period for Mesoblast... it is going to change rather quickly IMO.

Where in the past couple of years, we've had a lot of interest and demand for the stock when expectations were very high ... the expectations are so low right now that any positive from the OTAT meeting of the other two FDA meetings on CLBP and CHF will result in a sharp re-rate.

Remembering all we need is for the FDA to agree that the results in the CLBP and CHF, whilst not meeting the primary endpoints in those trials.. could be used for filing if a second phase 3 RCT with the new primary endpoints showed clinical benefit. If that is the case, then MSB are more than likely going to get a partner for both to fund the second phase 3 trial.

For the OTAT meeting we have heard that CBER agree the new potency assays are reasonable (in vitro) and will need OTAT to validate the in vivo data which is in hand. From what Silvui has said, the in vivo results were a success... so I'm expecting OTAT to fall in line. Risk? of course... but the reward will be exceptional if the OTAT give MSB's new potency assays the rubber stamp of approval. Not only will it mean the BLA for Ryoncil will be ready to go for re-filing next year... but the COVID trial will also get the green light, and with that Novartis' collaboration will finally be able to proceed.

Don't think for a second that Novartis hasn't helped MSB with these potency assays and passed on their learnings on how to deal with the FDA and OTAT.. and don't think the FDA are not aware Novartis are waiting on the wings.

Wonder why MSB are hiring a senior staff member to deal with collaborations?

Goodluck all

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Hi Stockrock,
Last I heard the company was progressing with a EUA for
both CHF and CLBP.
Perin holds a lot of sway and just what the amazing data is we shall soon know.

As for CLBP the opiate problem has got worse with 50%of use from lower back pain.

Getting real interesting thats for sure.

Aloha.

MSB Price at posting: $1.62 Sentiment: Buy Disclosure: Held
7 Upvote

0 Great analysis

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MSB Trading 2021 - paradigm shift, page-8475

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