https://www.fda.gov/news-events/press-announcements/fda-approves-...

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms

@opel24v

I guess you should research the subject a little better before lecturing the masses.

@Phaedrus Splendid factual post. Thank you.

Apologies for my absence over the last month. Silviu and most certainly the Board have not covered themselves with glory over financial prudence in managing the finances of this Company. Mesoblast was on fumes when it finally passed the hat round. In my opinion, this is not an acceptable way to run a public company. Firslty it almost left Oaktree with the whip hand and secondly because Mesoblast allowed the shorters to calmly buy back their positions at year lows. Ironically, I suspect Silviu had the last laugh by finessing their participation in the equity issue. If shorters were aware how poorly supported it was by other institutions (evident from the placement of the rump of the retail offer and the fact it was not underwritten ) I suspect some would have kept the short positions running ?
I think it is pretty clear from the charts at shortman who has provided a decent chunk of the additional funds.
That being said, the conditions in biotechs have been appalling, perhaps the worst i have ever known. Not surprisingly then that M&A in the sector is waking up to depressed valuations. Equity markets around the world have effectively been “risk off” and surging interest rates have badly affected the securitisation market. I think the Company were perfectly prepared to look at securitisation of certain IP, such as their royalty stream from Temcell in Japan, but then realised that might crystallise an opportunity for Oaktree to make a claim on the proceeds. The Company were very keen to hint they would be able to manage by securitisation but they must have known that any Temcell securitisation on its own would not be enough. The rights issue was dilutive, especially for those who could not easily participate or did not have the resources to….but it was by necessity, so all should support it and move on.

The good news is that Mesoblast lives to fight another day.
Within months we should know if the additional data on the potency assay for paediatric sr aGVHD is acceptable to the FDA. If not we will have to wait for the adult trial to conclude…but not as long as some here might think for news flow to massively affect the share price. Remember, the read out opportunity, as the primary endpoint for this condition is invariably 28 days with 6 months as a key secondary.
Personally, we must all accept the possibility that based on their record to date, the FDA might still prefer to wait until both trial our concluded. However, i also see another likely outcome in “accelerated approval” being given for paediatric post full enrolment in the adult trial . It would be churlish of the FDA not to do so and there is now a recent precedent for such an outcome. For those sitting this one out on the fence , the recent written guidance by the FDA regarding refractory populations in GVHD explicitly deals with any misunderstandings the mischievous posters here are trying to exploit.

We should all recognise the statement from Silviu that he was in “advanced discussions” with other potential deals. Despite the fact that on paper the Company has only 9-10 months of headroom (without further deals which I feel are highly likely)….i feel that there is too much potentially baking in the oven to make us extremely happy in the New Year. I am therefore changing my own sentiment to “Buy” . This does not reflect the technical position in the shares, but instead the absurd valuation of the Company. If the new potency assay is accepted on its own , I would not be surprised to see a major revaluation of the shares.

Lastly, may I wish all posters…well almost all posters.. a very Happy and prosperous New Year !. OP



Please do not rely on any of the facts or opinions expressed in the above post when making an investment decision. I have recently purchased shares and may be heavily biased in my views.