Speaking of wonderful SH, glad you are here to defend your investments honour as always. But to not upset Julius, lets focus on the content of your post vs the poster, your motives and history.
You have a contrary opinion to mine, call it outdated. You are entitled to your opinion, which you have expressed many times. That doesn't make your opinion roght nor mine wrong. The next few years however will show who was right. Maybe neither of us. The approval is a first, the new FDA approach under Marks is a first.
CYPs approach is targeting HR-aGvHD in adults, MSB gained approval in SR-aGvHD in pediatric patients of 2 months and older. Why not in adults? Approval for MSB in children with SR-aGvHD (only) won't slow down recruitment of CYP's trial in HR-aGvHD adults, if anything, eligible adult patients amd their doctors now might be more willing to actively look for alternatives to Rux. Then they must make a decision: 1. Off-label use of Ryoncil MSC treatment at a cost that your average patient in the US is unlikely able to afford, which may require them to get medicare/insurance approval first while the clock is ticking (the earlier the treatment starts the better for patients). In the absence of any current adult clinical data, that off-label use to this day would still be on the back of a failed randomised P3 trial of an older version of that product. 2. Participate in a free clinical trial using another MSC treatment.
Fortunately I am not in the situation that I have to make that choice myself, but it is a tough one to make. Again, we will see what the uptake is going to be over the next few years. But keep repeating your opinion to convince everyone including yourself that you have it all figured out already.
Speaking of clouded bias: the new messaging? Did you even read the letter? Care to share what PMC#3 may be? What has MSB committed to do in their letter dated 15 November 2024? https://www.fda.gov/media/184605/download?attachment Smart move, show commitment to run a trial in adults in exchange for approval in children. That sounds like something Marks would suggest to do based on his interviews, covering the to-date (clinically) unproven responses to CRL#1&2. The approval is based on the potential of treating a life-threatening disease in the most vulnerable patient group there is, therefore it is not only justified, but also well overdue. I know JB disagrees, but I am not bound to any moral code. My opinion is my own, it is based on what I see and read and is not intended to please anyone on HC.
CYP Price at posting:
21.0¢ Sentiment: Hold Disclosure: Held
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