Great testimony and comments:
Sojourn (yahoo forum)
Looking forward to Adcom meeting. A defining moment for Meso and a new era in medicine. Look at Dr Kurzberg's credentials. Duke University School of Medicine. To call her a key opnion leader doesn't do her status in the field of pediatric oncology justice. Hey, what do you know -- two other voting members on Adcom are also from Duke. Happy coincidence. Seriously, there will be no issue about seriousness of these children's illness, the fact that there are no existing therapies that offer the same durable response and that do not trigger terrible side effects. Safety -- there is absolutely no safety issue. Will the FDA insist on a blinded randomised trial for children dying from a shocking disease thereby forcing 50% on them to placebo. Not likely. There will be a vote at the end of the meeting and in all probability it will be favourable. FDA approval will almost certainly follow. Perhaps there will need to be a post marketing follow up/reporting as part of a phase 4. Nothing wrong with that -- it will provide useful support for future label extensions. Watch out shorts because it will soon be pay back time. Will Meso be in a trading halt on Thursday? Shorts better get a move on -- closing time is near.
LongStock
Comment from a GvHD survivor posted at the FDA website:
"My doctor said that there was a possible solution, a drug called remestemcel-L. Fortunately, I
was able to receive a course of the drug (for compassionate use), and within a matter of
weeks, my rashes receded, my abdominal pain abated, and my liver function returned to
normal. After a while, I was able to go kayaking with my dad and hiking with my mom. And, I
was even able to have ice cream. To this day, I have not suffered further complications of
GVHD or any side effects of remestemcel-L."
DYOR!
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