In reference to this study
https://jamanetwork.com/journals/jamaoncology/fullarticle/2497879Specifically,
"There was agreement between ODAC recommendations and final FDA approval; FDA approval was received for all 41 drugs that ODAC recommended approval.". In other words, the approval rate for cancer related drugs recommended by ODAC is historically 100% between January 2000 and December 2014.
This is no doubt a good sign for Ryoncil being potentially the first stem cell treatment approved in US.
As we all know the challenges involved in getting a drug across the line, in the event that there is no Covid vaccine that can show their efficacy in prevention and that Ryoncil managed to maintain the same efficacy as per the earlier small scale trials (e.g. ~80% survival rates),
it could potentially become the only viable treatment (that reduces mortality rates which the main concern of Covid19) available for the northern hemisphere winter season. The following are some of the publicly announced deals signed by countries (just) to secure their vaccine supply:
1. US - AstraZeneca - 1.2 Billions USD
2. US - Pfizer, BioNTech - 1.95 Billions USD
3. UK - Novavax, J&J - Undisclosed
4. US - Moderna - 1.5 BIllions USD
5. EU - AstraZeneca, Sanofi, GSK - 2 Billions EUR (emergency fund)
6. ??? - near term revenue potential for MSB - ???
Also, with the approval of Ryoncil (finger-crossed), MSB would be the only company with the know-how IP for large scale MSC productions.
Yes, there are a lot of ifs above. So, please do your own research.
Glad that we are finally seeing light at the end of the tunnel after so many years. GLTAH!
(20min delay)