@whenwill - I'll just go through my thoughts. This is how I've justified for myself.
But, each of us need to come up with your own conclusions.
Risks from above:
1. Trials may fail
- Which trials are we looking at?
- Ryoncil (aGVHD)
- that's close to 100% approved. FDA had a rolling review, if there was anything that they didn't like, they would have flagged it.
- Also, Priority Reviews are not given lightly - so why did Mesoblast get one?
- Covid-19 ARDS
- Firstly, it is the same product as per Ryoncil.
- We had two known results.
- The 12 person EAP was specifically for people on deaths door, after all other treatments failed and we still managed 83% success rate.
- Then we've recently heard from Sunjay Kaushal (investigator for the University of Maryland arm of the trial). 6 patients enrolled - 4 recovered and discharged. NIH backed trial, with well credential hospitals - all wouldn't agree on a whim.
- CLBP - Grunenthal gives me a vote of confidence
- CHF - If there is one indication that SI (given his background) is heavily involved and want to succeed. This is it! Also, @otherperpective has prodided a lot of confidence here
2. Pharmas put up a big fight against disruptive technology, i.e. MSC
The fight has been on-going, but the $$$ sign from disruptive will drive a rethink
Look at other industries and what happens when weight of evidence has tipped over to the disruptive energy
Large companies have to adapt or sink
3. Change in manufacturing may require more trials
Can you imagine if Rem-L is a proven solution for Covid-19 ARDS. But, there is a manufacturing road-block.
What would the FDA do to facilitate this change in manufacturing? Some other emergency approval measures?
4. Partners may drive down royalties %
This is unlike to happen with late stage trials.
Also, it is all about demand and supply.
If Rem-L is a proven solution for Covid-19 ARDS; how many manufacturing partners will line up?
5. Competition may catch up quicker than we anticipate
Look at other threads - mainly b@LeftYahoo for in-depth analysis of our competitors
6. Political drivers may prevent Mesoblast from being the solution for Covid-19 ARDS in the US
All that required here is manufacture in US!
Ticked - easy to sell for Trump
7. MC (hence, SP) is too high for a spec stock
CR was raised at $3.20 and quickly snapped up.
Yeah, but why MC is so high for a spec stock - because, we are at the pointy end of a company going from research based to commercialisation, bringing with it a paradigm shift in medical treatment. That's quite unique and full of huge potential
Phew! There's are all my thoughts. I'm happy to discuss
GLTASHs
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