It’s 9.00 Sunday hereGiven the extended waiting period is...

It’s 9.00 Sunday here
Given the extended waiting period is extending for another week at least, factual informative posts on HC have been a little thin. Absolute Gems however from @stanjupiter (Stan) regarding SRGvHD. Anyone not following that poster, highly recommend you do and read that post. I’ve read it 3 times now, hopefully slowly sinking in. Makes me regret the hours I spent standing outside the classroom. There was also a interesting series of posts in cell therapy thread and it is these and Stan’s posts that got me thinking about the investment case for Mesoblast.
There are some big calls to make over this company. Until we have a product to sell we are vulnerable to some extent. Are we the victim of a corrupt/incompetent/discriminatory system? In other words will we ever......
@LearningEachDay brought to our attention an article questioning whether the FDA is getting tough on bio tech’s (cell therapy thread), produced in full by @quartear, who also informed us of ALS being it would appear, knocked back by the FDA and pondering should they go it alone.
All this may at first appears to be negative for our sector and that has been reflected in a fall in the biotech index generally.
But depending on how you view these articles and recent history (including our own) is this our almost last nail in the coffin or a predictor of long term lasting success?
Clearly as a holder of Mesoblast I believe the later and I hope that the FDA is a tough as nails on the antics of pharma companies gaming the system with carefully crafted trials that it would appear do their best to avoid the “first” law of medicine, DO NO HARM!
Let’s hope that the FDA take a “tough” look at Ruxolitinib for SRGvHD against the do no harm standard.
Apply that standard to the long term prescription of opioids for CLBP as well.
Again in that article the FDA have called for an advisory panel on a Alzheimer’s drug, just a month before a decision. Fantastic, so real safety and efficacy, and not the “cheating “ that has been going on in trial designs will be the benchmark going forward? Of course the market is going to be nervous. Real breakthroughs are hard. Efficacy as a real measurable improvement is really hard and doing it safely is harder still. Think of all those billions that will need to be risked looking for the “golden tickets”. It is why small bio tech companies suddenly get snapped up for ”stupid” multiples at a certain point.
The FDA have also spoken about the length and cost of trials, is there another way? Of course if they want to make one.
All this is for me as an investor in Mesoblast very reassuring. Biggest risk to my investment is IMO my willingness to hold.
We have a great safety record, the data supports efficacy as real improvements. Confirmatory trail? Sure but in key areas, not long and not expensive.
So the higher the bar the better for us, they just need to be consistent and equitable. And in that area, I expect to see a number of deep pocketed (looking to share in that “golden ticket”) pharma companies prepared to help.
I am not going to pretend this has not been a bumpy ride, (The FDA decision on SRGvHD was a blow, hopefully none of the followers of this forum will have lost children because of it.) but that’s the sector and unlike many it would seem, we have something that works!
So as long as I can keep (as those famous investors Mick and Keith wrote about ), time on my side, I believe that this last weak has strengthened my view in the investment case for Mesoblast.
regards
Yelrom