Jeez Louise guys, this has turned into a zoo hahahaha.
I think people could do with some perspective as to what has gone on.
We have numerous catalysts due:
- GvHD update regarding the dispute (6 month delay stated by SI which would have been end of March, we're past this by a month)
- CHF update regarding approval pathway (results published Dec 15th, further analysis released Jan 11th, a type B meeting with FDA will be required to talk this over)
- CLBP update regarding approval pathway
- ARDS data readout (60 day follow up complete Feb 14th, 2.5 months past this, awaiting reporting from NIH, analysis by third party)
- Novartis partnership update (pending review of ARDS data)
- CHF partnership potential
A type B End of Phase (EOP) meeting takes ~84 days from the date of request. I assume MSB will need to write up the results and get the data into a form that is appropriate to present prior to the request. This is definitely due but not outrageously late - but also there is likely a back-and-forth dialogue with the FDA.
So that's timelines, all of that stuff is still due and we should be getting an update regarding all of that in the next couple of days.
I would like to make a point here - when the share price goes down without news, that's kind of good for everyone except day traders/short term investors. It gives shorts a chance to exit their positions and it gives longs a chance to price down and accumulate. If you're happy buying a stock at $2.50 and it goes down to $1.73 on no news, that's either a buying opportunity or you didn't do your DD very well.
No news does not indicate bad news, but it does leave us in the lurch which is poor communication. I trust that with the companies' team and portfolio, they will not go against the disclosure requirements of the ASX. If they get negative news they will release it, at worst putting a positive spin on it. There must not have been anything worth reporting (which suggests that MSB needs to start overestimating timelines because they have a track record for this). A 25% loss in value in a company because they aren't providing regular updates? Seems a little extreme to me. Granted, they should be criticised for the lack of communication and clarity in the next teleconference.
What do we know fundamentally?
- We have a cash runway of >1.5 years. No matter what happens to the share price today or tomorrow, the company will not be bankrupted. short of an apocalyptic scenario.
- Novartis signed an >$2b deal with MSB. Yes, that trial failed to meet the PE. But that's validation by a massive big pharma player that they like our IP, market potential, and market position. Athersys already had an ARDS trial, but Novartis came to us so that's a tick in that box.
- There are no adequate treatments for the progression of heart failure. We have a product that reduces mortality by 60% in early-stage disease and halts disease progression.
- More people died in San Francisco from opiate overdose than Covid-19 https://ktla.com/news/california/staggering-surge-in-drug-overdose-deaths-far-outpace-covid-19-fatalities-in-san-francisco/
- We have an opiate sparing agent that, after a single injection, lead to prolonged and enduring pain relief for up to two years that also reduced the consumption of opiates by the end of the trial by ~3-4 fold (placebo increased, treatment group nearly halved)
- FDA agreed to a single-arm trial for GvHD.
- Query over whether MSB had misleading language over having a pre-approved historical control for GvHD. Likely to be a non-issue but that's just imo.
- Mechanistically - and with the studies on ARDS to date (see my other posts) it makes a lot of sense that Remestemcel-L with provide therapeutic benefit to Covid ARDS sufferers
- What benefit will the trial show? Will that be sufficient for further development? Will it hold Novartis? That's speculative.
With regards to Novartis - they
- Clearly thought we had a strong IP position
- Thought we were industry leaders
- Thought that it could be manufactured on a commercial scale
- Thought that it would provide a therapeutic benefit (>2b partnership deal prior to results)
- Thought it would be a worthwhile investment as ARDS will be around for a while.
You guys need to calm down and consider price averaging down lol
All my opinion, not investment advice.
Gang Gang
(20min delay)