@MJC73 one of the humbling aspects of this forum is when posters are kind enough to share personal stories of actually what the potential impact of what Mesoblast is developing. The frustrating aspect of this is the the use of the word potential. "having or showing the capacity to develop into something in the future". Whilst all of us who are invested are obviously biased, we have "shown the capacity to" already. What we have to do is negotiate the obstacles to be "allowed to".
The FDA it seems when dealing with Inflammation are allowing the following:The use of Opioids to mask, the side effects and failure rates of the chosen drugs used to treat leading to lives ruined by crippling pain, life changing surgery, and death (sometime in horrific circumstances).
Now they have an option, that yes requires them to go through their processes of approval and it is right that they are diligent. However we have shown no side effects and we are "reasonable". So far every time we treat "inflammation" at the right time (sweet spot) we "knock the ball out of the park" while doing no harm.
I do not believe that the FDA consists of uncaring individuals. They have enough powers should they chose to exercise them to grant EUA or some other "title" for any use where the treating physician needs to treat the inflammation and either the effectiveness or side effects of current options are not suitable. There would not be one parent or patient who would not sign up for Rem-L or Rex-L if given the option.
Fantasy perhaps but it does appear to me that the "pathway" is becoming a "runway" that is (Cashflow or Joint Venture will provide) straight enough and long enough for us to start flying. Hopefully it will happen to help your partner and many like her soon.
Health, Wealth and Happiness, there is a reason why Health is first.
I wish you and your partner all 3.
Regards
Yelrom
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