Well the New Year starts for Mesoblast again tomorrow morning. Lots to look forward to
I believe that all the long term holders (of which I consider myself one) would have had just the best late christmas present ever in the OTAT update on the 31st December. Language is important and the context in which it is used is often just as important, none so more that with this update.
Should it have been "price sensitive"? Yes (imo) for those who understand the language and the process.
It was considered "No" in the release because Mesoblast also understand the language and the process and the importance of respecting that process.
So while it was not enough to prevent my ignore list posting furiously (will anything?), it was more than enough for me to celebrate New Year's Eve with a quiet (actually I am screaming from the rooftops) confidence that all is well.
It has been said by many that the FDA had made clear that they were looking for "reasonable" markers to judge. The release makes clear that they find our "markers" reasonable. Big massive tick. Now based on those, we will submit the data that shows using those markers how we work. This is all part of the well established "dispute resolution" or "appeals" process, call it what you will. It is a process, we have to follow it and we are. Each part of that process we are "ticking" off. High bar is good for us, because what we have is good. Other companies in this space simply do not have our patents.
Come on be honest, who was expecting that fantastic news on CLBP with this trial news, which could not have been designed any better for what we have to offer?
You would have thought that the FDA actually want us to bring out a non addictive, simple to administer (relatively) treatment as an alternative to Opioids. Hold my hands up, I thought CLBP was on the back burner (excuse the non-intended pun).
Heart - FDA to Mesoblast, pick the most vulnerable group that you can help, go on be really specific and then come back to us. Suddenly I am picking up this new acronym. Just learnt OTAT and now we have RMAT and the 21st Century Cures Act
As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if:
- The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;
- The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
- Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition
Now again I am not a medical man, I read what I can (again full credit to those on this forum) and I can see points A and B. But C? We are not preliminary, we have 5 years+ of data from a gold standard heart trial (stage 3 I think) to support A and B and when applied to the most vulnerable, well if I could think of a better word that spectacular I would use it. So why am I reading about RMAT for where we are in the process?
Could it possibly be that the FDA are trying to get through the process as quickly as possible as they realise that they have one of the greatest leap forwards in medicine since Viagra (my goodness I am so shallow, should have said Penicillin) ?
Now Crohns and other gut issues are a tad behind Heart and would seem to me to also qualify for RMAT because A and B are easy and C is because it just seems to work with no side effects. Everything out there seems to have side effects except us. For those being poisoned while trying to be "cured" I expect they would call it an unmet need.
Having been delightfully proved wrong about CLBP going quiet, I am not ruling out Covid Ards with the NIH as sponsors coming back into the spotlight. I am still hoping for those more knowledgeable to comment on the 68 years old who was treated successfully for the intestine transplant with REM-L. No problem with his immune system not being able to respond to the inflammation in his new gut. If the trial does go ahead, it will be strictly controlled as to when it is administered and to whom. Some will be enhanced dosing regimes to allow for age. We all ready know that in the sweet spot in works so we can expect success.
All these processes, like all potential partnership agreements, will be going on in a professional, focussed manner. We are LTH's we know this. It is natural to have doubts sometime that is a reasonable response. But remember that "reasonable" has already been passed.
They say that Sentiment (a view or opinion that is held or expressed) is driving the market now. I am not sure if I agree. The shorters are using "ignorance" to manipulate the market, hence the large short selling position. Sentiment has nothing to do with the processes that Mesoblast are engaging in with the FDA and potential partners. The only thing that matters is the data and how it applies to for instance the "reasonable "potency assays" and the p values that support that data.
So 2022 is an exciting year to look forward to. Mesoblast and the improving Arsenal. Life is all about balance. For all the success of these 2 to look forward to, I can see nothing good when it comes to Test Cricket. So if any of you know where we can find two opening bowlers, two opening batsman and perhaps a top class spinner who qualify to play for England, I would be grateful. I have no idea what processes the ECB are following but success does not seem part of it.
Regards
Yelrom.
(20min delay)