Looks like it is the old buy on rumour and sell on news...
Well the latest news is in and that's the ODAC briefing notes.
I'm not a scientist, so I'll leave other posters to interpret the notes and the documents associated with the ODAC review, but let's take a few items into consideration:
- Ryoncil is not a Drug - but, the FDA BLA process is a drug based process, so there's going to be some complication with this
- Manufacturing challenges are a few fold:
- Consistency cannot be compared to drugs
- Limitations with big production quantities
- FDA has guided Mesoblast through rolling review and priority review, and all of the above is known
- Ryoncil is addressing a niche market, so the production quantities is not an issue. There was enough volume produced for all the trials and subsequent EAPs, including the current Covid-19 ARDS
- If production quality is a concern, then why would FDA allow for Covid-19 ARDS trial and MIS-C EAP
- Real life data with JCR Temcell - should be used as an example of safety, quality and quantity
- SI & Team is well prepared to answer all of these queries - it is nothing new to them. It all part of the ODAC process
- ...
And, lastly this is from Mesoblast submission
"The demonstrated efficacy and favorable safety profile of remestemcel-L address a significantunmet medical need in pediatric SR-aGVHD patients, especially in children under the age of 12years old. Considered in the context of a serious condition for which currently availabletreatments have limitations, the totality of evidence substantiates the highly favorable clinicalbenefit-risk profile for remestemcel-L in the treatment of pediatric patients with SR-aGVH"
...
So given all the above, where is the SP likely to go today?
Jittery SHs will sell out
Professional sharts will push even harder to exit
Naysayers will jump back in and post more today
We'll have the swift retrace that I was looking for yesterday, but unfortunately with more punch today due to the above.
But, then the demand vs supply equation will stabilise and the SP will head up again.
We should close in the $4.70s range, I'll go with $4.72
HODL was never going to be easy, this is where the conviction to HODL will be tested
(20min delay)