2023 The Final Countdown, page-14

Here we are, not 1 / 24th of the way into the year, and MSB has confirmed the BLA resubmission is at the puiblishers, to be on it's way to the FDA shortly. Even the downrampers have conceeded it is going to happen. Their doubt has been removed you could say

But what will happen to the share price and when?

Assuming we will shortly get confirmation that BLA has been lodged through the publisher.
Assuming the FDA accepts the resubmission and provides a PDUFA date, and
Assuming the blockbuster CLBP trial commences before the PDUFA date, and
Having a really close look at the firstime around for the BLA

31st Jan 2020 - > Mesoblast lodged the final BLA application module , Share price was around $3
16th March 2020 -> Share price had dropped to $1.21
31st March 2020 -> FDA accepts Mesoblasts application, sets PDUFA date for September
April 2020 -> SP $2+
May to June 2020 -> SP $3+
July 2020 ->$4
August 2020 -> $5
Sep 2020 ->$5 prior to the CRL
2 Oct, CRL issued, price dropped to just over $3 from almost $5

A famous wise person once said that past performance is no guarantee of future performance.
In this case both by way of outcome ( CRL ), and also by way of SP value.

However I think you could say looking at the 2020 BLA that MSB lodged, which resulted in a 400% share price rise before they even got to the PDUFA date, which turned out to be a great big no from the FDA, that there must have been a lot of excitement with people, companies, funds longs, jumping onboard in anticipation for what was about to unfold.

That was not the only pie in the oven at that exact time however. Novartis were not in the picture at that stage, but the company was running the COVID ARDS trial, and the pilot did have great mortality results in under 65's.

Now I'm expecting a PDUFA date, probably in Q3 2022 as I'm a pessemist, and if the FDA took an entire 6 months from accepting the BLA the first time, you can probably bet it will be the same the second time. By this stage the company should* have initiated the final CLBP trial. This is the monmeymaker. The trial that has had nothing but repeated good results from phase 2 to phase 3, in double blind placebo controlled trials. All they need to is repeat the results a third time, and that is enough efficacy for approval.

So what does all that mean.

I think by the PDUFA date, the SP would have moved in one overall up direction.
There is a fair chance these sub $1 party prices will never be seen again, even if the application fails.
Following the first CRL, the SP initially fell to $3, and then spent another 1 year, 7 months until it reached sub $1 mark, where it has been hanging out recently. That was not with a pivotal CLBP trial running, that has demonstrated outstanding efficacy so far in 2 seperate trials.

Considering paediatric SRGvHD vs CLBP is like talking cents vs $100 bills.
Paediatric SRGvHD was only ever likely to treat up to 250 - 300 patients per year after 3 years of market penetration like Temcell achieved in Japan.
CLBP has over 300,000 lumbar spinal surgeries performed every year in the USA, and currently over 70 million american's are suffering from Chronic Lower Back pain. https://www.ncbi.nlm.nih.gov/books/NBK538173/#:~:text=Back%20pain%20is%20widespread%20in,the%20adult%20population%20%5B12%5D.

Not only will Mesoblast be positioned as a cheaper option than complicated surgeries, but so far the efficacy is far better, and far less invasive than expensive and dangerous lumbar fusion surgeries, or synthetic disc insertions.

So in summary, I don't have a target price. I just think it's massively undervalued today, and will start to creep up to show some of it's potential over the next 6 to 7 months.

However, just like in 2020, that upward trend may not start until the FDA accept the application. ( It actually dropped 50% between submission, and FDA accepting last time - go figure ), but then climbed over 400% approaching PDUFA