MSB Trading 2021 - paradigm shift

Happy new year - may 2021 bring happiness, heathand a prosperous year to all MSB believers

SP wise, 2020 has been a lousy year, so let’s leave that behindus and start the new year with a new thread

The main question that I had to ponder over the last few weekswas… has the Mesoblast story changed?

I've got a new pair of rose tinted glasses - so let's roll

Let’s have a quick review of 2020 before we move onto 2021.

2020 in review

Leading into 2020, we had three P3+ trials (GVHD, CHF and CLBP)and then we got a bonus P3 of C19 ARDS.

It has been a huge learning year and tested our mettle!

Iwould challenge anyone to put their hand up and say that they fully understandthe BLA process, what ODAC is all about, what's a trial design entail

It's a learning process and we are all learning, including theFDA and Mesoblast in response to this once in 100 years pandemic

We had so many false starts, including leading into December wehad lots of catalysts and I was really excited to see how things would unfold,but unfortunately the market did not like the fact that each of the two trials (CHFand C19 ARDS) did not meet its primary end points

So has the Mesoblast story changed?

Well on the surface, it’s not as rosy as the start of 2020 (oreven leading into Dec 2020).

Let’s have a look at each “failed” indications

Ryoncil (GVHD) – likely to enter into an FDA dispute processwith:

·ODAC9-1 vote
·MSBWins Fierce Biotech Innovation Award for Remestemcel-L
·Beenused in Japan for 4+ years, without any safety concerns
·FDAgave a rolling review, a priority review and Fast track designation

Now, I’m not a lawyer, but common sense would say – we have avery strong case here for an Accelerated Approval.

Did the FDA lead us astray? Why didn’t they inform Mesoblastthat a single arm trial was not sufficient for approval?

I believe it was @otherperspective that mentioned that there wasa change with the lead FDA reviewer, and therefore what was discussed andagreed with Mesoblast was changed by the time this got to the BLA

CHF – paradigm shift!

60% reduction in mortality!!!!

Now, was this a failed trial or a trial that didn’t pass theprimary end point, but unlocked an even more impressive secondary end point?

SP wise, the market has dismissed this The question I would ask - is the market correct all the time? hmmmm

But, will the potential partners dismiss this? Will the FDA?

NO WAY!!!

This is huge and will take centre stage for Mesoblast.
We shouldhear a lot more of this in Q1 2021

C19 ARDS

This has been discussed to death, so I won’t go over it again.

Suffice to say – just wait for the data.

I believe it was @LeftYahoo who pointed out that technically thetrial did not stop, but it just stop taking new enrolment – just think aboutthat. Did the trial actually failed?

The main question to ask here is what does Novartis think?

Will they bail out or not.

Personally, I don’t see Novartis bailing out.

First of all they would have done their homework.
A company like Novartis would not have spent valuabletime to negotiate with Mesoblast, and then only to pull out at first chance.

If the results of this trial was their primary concern, whywouldn’t they have just delayed the collaboration with Mesoblast for a few moreweeks/ months to wait for the C19 ARDS trial to finish first?

No – they proceeded to sign an agreement with Mesoblast.

Novartis have done their homework.

Fierce Biotech Innovation is not gimmie either

NIH must have seen enough to sponsor the C19 ARDS in the firstplace

CLBP – I’ll give it two weeks

I’m glad that the announcement was not released during the XmasNY break, as it would have more likely been bad news.

Now that it has been delayed to the 2021 – I’m more swayed to apositive outcome and it is likely to be released in the first two weeks of January.

2021 – paradigm shift

So has the Mesoblast story changed?

Not yet for me.

It has definitely hit a few bumps in the road and is on a detour,but the ride is still pretty much intact.

Mesoblast is brining a paradigm shift in medical treatment andwith that there is a burden but also huge rewards.

Sure, there are risks to all of the items I’ve listed above, butthere are also huge rewards.

It’s up to each of us SHs to determine our own risks level.

So please do whatever you want to do to ensure that you arecomfortable with your investment.

For me, I’m HODLing and will ride this out.

I'm excited by what 2021 got installed for usMSB believers

I'lllist a few catalysts, but I'm sure I'll miss a few too:

1.CLBP readout
2.Potential partnering deal for MSB’s chronic discogenic lower back pain(CLBP)
3.Ryoncil FDA dispute process confirmation
4.C19 ARDS data readout
5.Novartis partnership confirmation (after waiting period)
6.Heart data confirmation
7.Potential partnering deal for MSB’s congestive heart failure product
8.Increase in royalties from TEMCELL
9.Grunenthal updates
10.Tasly updates
11.The MSC-100-IV for the expanded indication
12.JCR Epidermolysis Bullosa (EB)
13.Takeda updates
14.1,000+ patents and other left field partnerships
15. Additional trials (e.g. all cause ARDS)
16. Other jurisdictions (e.g. EU)

I'm very bullish and bias on MSB

The sharts have lots of outstanding shortpositions, but against that I look at SI, T20 and T100 - have they been sellingout? Apart from Capital, there were no other sellers? The majority of these large holders have heldand/ or built on their positions

So when you look at the paradigm shift intreatment, once it starts the snowball effect will be a lot larger thanexpected.

I'm excited by what 2021 got installed for us MSBbelievers
And thank you all in advance for your valuablecontribution and banter

GLTASHs
Onwards and upwards

Disclaimer:
Like a few here, I'm investing into MSB withconviction, as it is a major part of my early retirement plan
But, I understand that we all have different sizepockets and risk appetite
So please DYOR, I'm just musing out loud here, soplease do not invest base on anything I've written

A new year, a new resolution – play nice everyone!

New trading thread

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