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$1.13 mesoblast limited

Thanks for this great summary.I have one concern, and that is...

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RickyH

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30/12/20

08:16

Post #: 49856721
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Originally posted by DeputyDawg: ↑

If you look at the blaster today relative to a year ago you would absolutely say it is going in the csl direction as the opportunity set continues to increase rather than decrease . The trouble is the company remains half pregnant and has yet to get to the promised land of fda approval for a product in spite of the fact that it remains tantalingly close .

1. On gvhd , as I understand it the blaster was given a clear Avenue for approval via a single arm trial in clear black and white . The trouble was at the last minute there was a changing of the guard regarding the case officer who decided to completely change the terms of reference as people often do when they are attempting to stamp their authority on things ( I think she is the person on the odac meeting telling one of the members to ignore the fact that Jakafi had a single arm trial). That is not the fault of the blaster it is pure bad luck. I do not think all is lost as what has happened is so egregious that even an American body will look within themselves but that may well be wishful thinking .
2. Respiratory disease was not a part of the meso portfolio a year ago , but with the entrance of Novartis and a US dollar 1bn odd injection has a clear path to proving up efficacy in a whole host of respiratory indications . What seems to be coming out of these trials is that stem cells are particularly efficacious when they are applied relatively early on in a disease treatment rather than as a matter of last resort . In the case of COVID 19 it was clear that in the early phases it worked really well but as time went on and patients were kept off ventilators until the very last moment , stuffed full of all sorts of drugs , stem cells did not work . This does not mean that it will not work in ards when treated early or in copd or in pneumonia or in asthma or all sorts of respiratory ailments . What is coming out is that stem cells should be a mainstream treatment not one of last resort which massively increases the available market .
3. In general people had a whole load of misgivings about the heart trial . When I saw the results and I consulted with a heart specialist here in the usa , I thought h my god they have absolutely killed this trial . I still think that having been referred to other specialists . Indeed I have heard recordings of the prof saying that if we can get improvements in mortality of more than 20 percent we will have killed the trial . L remind everyone they achieved 60 percent . Most importantly stage 2 patients is the relevant market which is a far larger market than stage 3 . Any pharma company worth its salt is going to be all over this and I believe they are according to the rumour mill .
4. The clbp trial is yet to announce but one can see a pattern emerging that if stem cells are administered relatively early on they have a lasting and significant impact . Remember they chose the cohort for the phase 3 portion far more specifically than the phase 2 and grunenthal , being German , did a massive amount of homework . I am v optimistic about this trial , more so than heart but what do I know .

the most disappointing thing is that this has been yet another year of unbelievable volatility which attracts all sorts of miscreants looking to take opportunity from announcements that have the ability to be interpreted differently and the gvhd decision was extraordinary and shows the Americans in a bad light as you do wonder if they would have done this to their own . Let’s hope we get great results on clbp, the fda reexamining their position on gvhd and more info on the heart data . Remember there are all sorts of other opportunities that continue to mature like crohns and rheumatoid arthritis to name but two.

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Thanks for this great summary.
I have one concern, and that is with the path aGVHD must take. I have another company (also Australian) where 'a changing of the guard' occurred at the last minute and a trial that was considered adequate was then rejected. Two years later they are still trying to have the decision reassessed by the FDA. I am not feeling particularly confident for those with aGVHD. If, in fact, an upstart's ego has overridden a decision that could have saved lives, then the system needs to be closely scrutinized.

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