Ann: Mesoblast Update on Chronic Low Back Pain Program, page-322

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Sailor1

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22/10/21

20:41

Post #: 57012135
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Originally posted by stockrock: ↑

Type C meeting with the FDA on CLBP results was scheduled for July/Aug... they didn't submit the request today, Silviu mentioned in the stem cell summit (at 32:55 see below video) which means they requested the Type C meeting sometime in June would be my best guess "we will be having discussions also in the next couple of months"... were his exact words.

US$150m was the original amount of upfront and milestone payments, which has now been reduced to US$112.5m. US$37.5m reduction probably due to US$20 milestone on EU approval to start EU trial no longer applicable, as well as other milestones related to the EU trial which are now not applicable.

This means that the EU regulator has given Grunenthal the green light that a US trial with only 20% participants from the EU would be sufficient for approval. We won't know what was discussed, but the regulator does not make the hurdles to approval less stringent if it wasn't impressed with the data it has seen thus far... the undeniable reduction in pain, and the reduction in opioid use (even after patients and doctors were told to not change their medication throughout the trial) speaks volumes on how effective this is.

On the US FDA meeting, IMO this is going to be a trigger for partners in the US to come forward. All the potential partners need to hear is that a confirmatory trial showing the same benefit in pain, and possibly a key secondary endpoint of reduction in opioid use.. would be sufficient for product approval. Function improvement whilst important, IMO has been overtaken by opioid abuse as a secondary key determinant of whether a therapy would be beneficial to a patient in the current medical field. I believe a US partner will be signed on to run and fund the US trial.. and with the Surgcentre network at their disposal, it is going to be a very efficiently recruited trial IMO.

I still think there is a chance of accelerated approval on the reduction in opioid use as a surrogate endpoint.. but this largely depends on whether or not the FDA consider opioid abuse as a serious condition that would warrant accelerated approval. A serious condition is defined as 'life-threatening' ... so whilst there is some increased focus on opioid abuse at the agency, I haven't seen anything given accelerated approval for opioid abuse. So with anything where it's a first... I would place only a small probability of success, and this is the case here for me. But as always, I'm hoping to be pleasantly surprised, as I know Mesoblast will be enquiring if this path of approval will be available to them, because the data is extremely impressive when it comes to reduction in opioid use.

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@stockrock

I'm sure that you have not forgotten this product bubbling quietly away in the background. It's a real sleeper imo and must "soon" be scheduled to come before the FDA. It's overdue!

The monies involved here have been noted as up to $112.5 million up-front from Grunenthal, double digit sales royalties in a billion dollar market in the EU. The bidding hasn't even begun for the U.S. market, which may double the EU market as estimated by @Longstock.

C'mon FDA. It's on your list somewhere

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