I'll quote ya!
" I'll have a better look on the weekend, but of the top of my head - try to cramp all of this in:
1) FDA approval of Ryoncil
2) Ryoncil commercialisation start announcements
3) Interim data sent to DSMB
4) DSMB recommendation
5) FDA review and approval of Covid-19 ARDS - another ODAC required? Hope not!
6) CHF readouts
7) CLBP readouts
8) Partnership announcements
9) A lot of little announcements in between too
Exactly my thoughts. Only reason why I highlighted 1) and 5) is because of the precedent that was set last night. I think not many people have truly cottoned on to how huge a watershed moment it was last night, having a 90% "approval" from the ODAC with the data sets that was used - the manufacturing process, the MOAs and how it modulates the immune response in terms of inflammation!
Just thinking back about that old video about the prof and the "Vatican" connection, courtesy of @The Yankee back in July
Link here -> https://hotcopper.com.au/posts/45649769/single
I truly think that last night is a springboard into almost every other extension that even remotely has inflammation in its MOA!
Which leads me to C-19 ARDS.
ARDS on its own, (source : Han, S., & Mallampalli, R. K. (2015). The acute respiratory distress syndrome: from mechanism to translation. Journal of immunology (Baltimore, Md. : 1950), 194(3), 855–860. https://doi.org/10.4049/jimmunol.1402513 )
Just reflecting on last night's presentation of the MOA of Rem-L and also the article about ARDS.. I picked up a few things that would be oddly familiar if you were following the Prof's slides...
I see...
1) M1, M2 macrophages
2) TnF-alpha
3) IL-6, IL-8
Ringing bells already?
Now.. this is where it gets even more interesting.
There it is! NF-kappa beta!! That the Prof referred to, over and over again!
This slide in particular! Phosphorylation of NF-kappa-beta that leads to the polarization of M1 macrophage to M2, which then has the downstream effect of immunomodulation!
I am very eagerly awaiting the readouts, the slides, that confirm rem-L's MOA in mediating this "cytokine storm" in ARDS, much less COVID-19 ARDS!!!
And its precisely because of last night, that we can very quickly springboard into the label extension (I believe!)
Exciting times ahead!!
DYOR and HODL!
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