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ddwn

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25/01/22

20:39

Post #: 59130574
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Originally posted by stockrock: ↑

As a few people picked up already, Mesoblast plan to take the CLBP product all the way to market themselves .. which takes away a potential short term partnership annoucement, but if they can fund and execute it.. then retaining the global ex EU/Latin America rights will be exponentially better for shareholders in the longer term.

It is a balancing act with pros and cons when deciding to partner up or go it alone.. partnering up only makes sense if you can't afford to fund the trial and/or do not believe you will be able to fund / market and distribute the product effectively. I thought that because the cash injection from Novartis was not received, that the need to bolster their capital position that it would push them to partner up CLBP, giving up the lion's share of the profits in the longer term (for an upfront cash injection and usually a dilutionary equity stake).

But it seems the scales were not tipped enough for them to budge, and the fact that they got such a favourable FDA outcome (12 month trial, single endpoint)... this second pivotal trial could be a very quick and cheap trial to run, aided by the network that SurgCenter has which will also make marketing and distribution of the product very effective and achievable without a partner.

CHF is a different story, in that they will definitely need a partner to both fund a potential phase 3 trial and market and distribute the product. So once Mesoblast obtains clarity on the next steps (is it another phase 3 trial, or is there an expedited pathway) they will be in a position to land on a partner. So a partner here is not so much a if, but when and who ... but they can't say much yet on the approval pathway until the FDA give them the formal feedback, which I expect to find out by the end of this quarter.

COVID ARDS also sounds like they are moving ahead with and it which can only be the case if the NIH is going to fund this second trial.

It's quite exciting to think that we could have three pivotal phase 3 trials ongoing later this year... with both CLBP and COVID ARDs potentially stopping early for overwhelming efficacy (if the second phase 3 trial results trend like the first phase 3 trial in the sub-groups studied).

But what is probably most interesting is that Silviu said that he hopes to hear positive news from the FDA's review of the Ryoncil data and dossiers over the coming months... that almost sounds to be that the Ryoncil resubmission has been lodged? It wasn't a 'if they accept our resubmission'... it was ' we hope to hear positive news from the FDA's review... we will be preparing to interface with the FDA... ". Maybe we'll get a bit more clarity on this at the quarterly update, but it would be interesting to know if the review clock has been started already.

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Thanks @stockrock @yelrom @Martin37 and other posters

I’m having a short break, so I appreciate these summaries.

Has the BLA resubmission already started?
If so, bring it on!!! We are one step closer to commercialisation!!!

Last edited by ddwn: 25/01/22

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