MSB (ASX) Phase 3 DREAM HF-1 read-out

Originally posted by stockrock: ↑

I've been taking some time to reflect on where we are .. and recalled watching this video of Silviu back in 2012 (which gets better after they fix his microphone) where he was sharing his personal journey from scientist to CEO of Mesoblast .. and his thought process on how to go about bringing to market an idea / belief that stem cells could be utilised to fill the void of some significant medical unmet needs such as congestive heart failure.

It's a worthwhile watch and puts into perspective how much goes into getting one treatment from idea to a phase 3 clinical trial... and a lot has happened since this video was filmed (which was filmed shortly after Cephalon's partnership with MSB's heart failure program in early 2011 + Teva's acquisition of Cephalon in late 2011 ), with the flagship CHF program changing hands from Cephalon to Teva in the space of a year.

With Mesoblast's phase 3 CHF trial (DREAM HF-1) commencing in 2014... Teva handing back the global rights to the program AT NO COST to Mesoblast in mid 2016, but not before doing a lot of the leg work with the FDA in setting up the trial and then convincing the FDA to accept the adaptive design, which is revolutionary in it's own right and could be the pilot trial design that could be adopted going forward. But here we are, six years on and we at literally day/days away from the phase 3 trial read-out..

To some it's a tough and anxious wait the past few days... just imagine how shareholders who have been waiting close to a decade for these results... or Silviu who has dedicated his life to this cause. This is not a time to rush... they could very well have earth-shattering data on their hands right now, and from what I've witnessed in the past.. you won't get a hint of excitement or leak anywhere. You will see from this video the type of person Silviu is.. he wants to do it the right way, he isn't into hype and he will let the data speak for itself.

What I found most interesting is how he described the industry landscape when he first set up Mesoblast... big pharma companies were not interested in new technology that could threaten their traditional drug businesses... why change something if it ~~ain't broken~~ is making you bucket loads of profits?

To me, Novartis stepping up as a partner for all-cause ARDS is quite possibly the first sign of a paradigm shift happening... this is a top 5 global pharma company that has seen something in the data that has been generated from Mesoblast's treatments that has convinced them to very rapidly partner with us. Where in the past large pharma's of their caliber and size would ignore or intentionally try and push out companies like Mesoblast... here we have one extending a hand. That's a very notable shift.

Some have raised the fact that Novatis has ex-US rights to Rux (Ryoncil's main competitor in SR-aGVHD) as a concern... I personally think that would be a worry for the narrow minded. Novartis have their own cell and gene therapy business, which means they are well aware of the paradigm shift that is coming, where conventional 'drugs' are going to be made redundant in many cases and will be replaced with a new paradigm of medicine. It's doesn't take a genius to work out that whoever gets there first will have many years head start ahead of their competitors and will be able to reap the rewards of lush unclaimed green pastures. Let's just say that I am sure that Novartis will be very keen to know the results of DREAM HF-1.

Just one last thought ... I hope shareholders can appreciate what Teva did back in 2016. They very well could have shelved the program.. they had the GLOBAL rights to it and it was worth hundreds of millions of dollars... but to their credit, they gave it every chance to succeed by gifting it back to Mesoblast in the hope that it could one day become a credible treatment for a very large global medical unmet need. And here we are, with global ex-China rights still available for partnership... this is one case of double dipping that I am very much looking forward to being a part of.

Goodluck all

Expand

There is a parallel with IBM back in the 70's, ? , where they suppressed the development of PC's internally as they were a "threat" to their traditional mainframe business. I guess a lot of managers guarding "their" silo and their bonus.

And lets not even get into the origins of Microsoft being triggered by IBM not embracing the whole PC ecosystem internally.

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Last updated 12.39pm 07/05/2024 ?

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