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Ann: Ethics Approval to Treat COVID-19 Patients in Australia, page-208

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02/09/20

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Post #: 47035284
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Originally posted by NuitsSonores: ↑

This is undeniably great news! It is laughable that some are trying to spin this negatively and as proof that Mesoblast is struggling with enrollment in the U.S. Ha! It seems like some are getting extremely desperate to bring the SP down before the pending interim analysis and FDA approval announcement. That or some are masochistically trying to convince themselves that their investment is wrong. Either way, this is ONLY good news, both for Australians (especially Victorians who are suffering through the tail end of their COVID spike) and for Mesoblast as it paves the way for registration and reimbursement in the Australian market.

The TGA and PBAC (Pharmaceutical Benefits Advisory Committee), like most health authorities, consider the FDA review process for medicines as the gold standard. However, it is always preferred to have demographic specific information (Australian specific in other words) data as extra ammunition. So from a clinical perspective, even if a small number of patients are enrolled before the trial is halted, that information will massively help the approval process in Australia.

This is also an Australian company, and Silviu Itescu is an Australian. And as he has said previously, he has a moral obligation to help Australians with their life saving therapeutics just as all Australians do. This is all the reason you need to start a rem-L trial here! The team at Mesoblast will sleep soundly knowing that they have saved Australian lives in the next few weeks.

For everyone asking why now? Isn't it late? Due to the lower covid-19 numbers in Australia in the early stages of the pandemic, it's more than likely that Mesoblast prioritised the setting up and implementation of the U.S. trial before shifting priority to Australia in the last few weeks given the surge in cases. They are following the hot spots and covering multiple countries and jurisdictions. For a small team, this is excellent management and resourcing.

If you are jumping at ghosts and reading into this announcement - put your head on straight and look at the evidence. We have clinical evidence that the mechanism of action in rem-L works in cytokine storms like those seen in covid-ARDS. We have multiple sources of evidence that MSC's work from different countries AND companies. We have a funded NIH trial across at least 17 states and now TWO countries. We have an almost guaranteed approval for sr-GVHD this month, which will allow a streamlined approval for covid-ARDS when efficacious data is obtained and we have
an extremely scalable manufacturing partnership with plenty of cash to boot.

In other words, we have a home run. HODL and enjoy the ride.

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Nuit, you just won a repost to the Yahoo US board... Great overview, thanks.

MSB Price at posting: $5.15 Sentiment: Buy Disclosure: Held
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