I just thought I'll start a new thread as the previous one got a bit too toxic for my liking.
As
@Armyne said, lets try keep things civil and orderly, but not take ourselves too seriously. All things trading of MSB on the ASX - predominantly trading, but all thought provoking and/or with some general banter is welcomed.
In addition to this, please follow the posting guidelines below from
@Zenox.
If you can't comply with this, then please don't post in here.
Create your own thread and post away!
...
ok, so where are we?
A new dawn is upon us.
Mesoblast has been on a long, arduous and costly FDA approval path for Ryoncil.
Today it will have one of it's most important meeting, the ODAC review, you can read all about it here
https://hotcopper.com.au/posts/46449348/singleAlso, have a read of this
https://hotcopper.com.au/posts/46492132/singleThe comparison to Novartis’ Kymriah the first CAR-T therapy and Jakafi is very relevant.
Why is this meeting important?
Approval at this meeting will be one step closer for Mesoblast to bring a paradigm shift in medical treatment.
This is huge!
Being the pioneer for the first MSC to be FDA approved, Mesoblast will have to wear the burden of a high hurdle to get over, but it will also be very rewarding.
Lucky for us, SI himself is very familiar with the FDA process, as I believe he was a former advisor to the FDA.
I've stated before, that as retail SH it is our lack of understanding of the FDA process that has been exposed.
But, do you think that these issues raised in the ODAC briefing notes are new & is a surprise to Mesoblast?
Mesoblast has a very good relationship with the FDA, and has followed FDA guidance through many years.
Why would the FDA leave a key piece of information from Mesoblast, but still take them through the charade of rolling review, priority review, EAPs & Covid-19 ARDS trial?Where is the FDA duty of care to these patients if they have issues with Ryoncil/ Rem-L?
I have no doubts that Mesoblast is on top of this and we'll see this in the ODAC review today.
This is a pivotal point for Mesoblast and as a SH I'm really excited that we are here now.
It is a new dawn - bring it on!
Those that want to attend the ODAC review, use this link here
https://collaboration.fda.gov/odac081320/...
And finally, this is from
@ZenoxNew trading thread
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