Jun. 15 at 5:45 PM
$SRPT $CAPR
The second patient's death is likely set off an alarm for FDA next week,
This will echo the concern that this new FDA Team has on Cell and Gene therapies.
This new death will likely to make them change the way they review Cell and Gene Therapy. IMHO
In Last week FDA's Meeting, Kennedy and his new FDA Team conclude that:
"CAUTION" and "RIGOROUS OVERSIGHT" are needed for both Cell and Gene Therapy.
On the other hand,
$CPIX DMD drug is chemical-based (not cell or gene) has been treated on 1,400+ patients in various trials,
and data shows it is safe.
Here is the video of FDA's conclusion of last week meeting,
It shows us the FDA's position on Cell and Gene therapy.