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$1.38 mesoblast limited

2022 ... Get your popcorn out!, page-17

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Kingtup

1,751 Posts.

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14/03/22

09:35

Post #: 60171486
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Originally posted by dachopper: ↑

Now is as good a time as any to have a think about when the exciting dates may be in 2022.

20th May 2022- Crohns control arm results.
The Crohns trial commenced November 4 2020, and the first update we received was 20th Feb 2022, based on the treatment of the first 12 patients reaching a 3 month point. The total number of patients the trial intends to recruit is 24 according to clinical trials website ( this has reduced from the 48 mentioned in the press release, maybe because the results are so positive.... or maybe they aren't updating clinical trials website regularly ) . The results so far are for the 8 treated, 100% remission between 6 weeks to 3 months (both optically and using biomarkers). 20th May marks 3 months since the control arm would have been moved over to treatment, and if they respond as well as the first treatment group, we should expect those that are going to go into remission, to be in it by then. They are checked at 2 weeks, 6 weeks, 3 months, and for the control arm at 6 months they are given another dose if they have improved. On the length of the trial, the company probably still needs to treat more people to confirm which of the 150 or the 300 million cell doses is actually the required dose.
https://hotcopper.com.au/documentembed?id=uOMxKKzFkiWRTLKhOROKAxjvSTYP6wm7zxiZreR7ke92GA%3D%3D
30th June 2022- GvHD BLA resubmission by now.
Based on SI's comments in the last webcast , that they are preparing to product launch and are "laser focused" for it to be later this year, and the fact that the maximum time for approval from the FDA legally is 6 months after submission. It would need to go in before the end of June for this to occur.
30th June 2022- CHF Feedback or Bombshell by now
This is my first real " guess" at a date in here, based on MSB saying they were formally submitting something, which sounds like it is likely happening this month. That gives FDA 90 days from the end of March to respond. It may happen a lot sooner than this however, since this is just a sub group analysis and FDA already have the previous data from back in December. If they advocate going for accelerated approval as a few people here suspect, that will be absolutely massive for the company. That means they no longer have to do a second trial ( which they have always assumed they would need to do ) , prior to commercialization. This news would in my opinion be the last time we see prices like these again, and so for me it will be time to make the last average down buys before it goes ballistic.
20th Aug 2022- Crohns control arm 6 month follow up.
According to clinical trials the control arm will be assessed at this time to decide if the treatment is working, and if it is will receive a second dose of Rex. This is the other timeline that I think the market may be updated, if it doesn't occur in May.
31st Dec 2022- Pediatric GvHD goes commercial.
This is it, the first " big one" that we are waiting for, and if all goes according to plan. MSB should be in the shelves of the hospitals in USA that treat approximately 50% of all pediatric GvHD cases. This date is based on the company saying they are ramping up for an approval later this year.
31st Dec 2022- COVID ARDS trial II.
I believe that the COVID ARDS trial may well be linked to the approval of Remestemcel. As soon as it is approved, the COVID trial will likely commence, or at least the FDA will approved the trial design ( if not done earlier ). Since the FDA said no more ARDS trial until the manufacturing is sorted out, the FDA may be waiting for the BLA resubmission before it even comments on the trial design needed for Covid ARDS II.
2022- CLBP trial II
At some point this year, I believe the next CLBP trial will commence. Your guess is as good as mine with respect to exactly when it may kick off. It will be interesting to see who the list of investigators is for this trial. If it is the same as the previous trial, and also if any of the Surgcentre owned clinics get involved.

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Are you say that 2 years after the 9-1 vote and the FDA saying no we might get approval. What in the world by as SI done over this time. He should be taking a pay cut and hand back any bonuses got.
imho
MSB Price at posting: $1.15 Sentiment: Buy Disclosure: Held
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