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Posted On: 01/04/2024 3:57:04 AM
Post# of 155142
i'm taking the perspective that the hold was a blessing in disguise
all the data that we wanted the FDA to look at, they halve seen as a result of the hold.
even now, in getting this subsequent hold lifted, the FDA even requested to see NASH's data so that they can appreciate leronlimab's anti-inflammatory and immune de-activating effects. They would not have looked at NASH otherwise.
The BLA was practically re-written as a result of the hold and if MDR was still an unmet need, we could have submitted it almost immediately and since they lifted the hold, they would have to approve, since it was good enough to get the hold lifted.
Without the hold, CYDY would now be spinning its wheels, not knowing what to pursue, all HIV is no longer an indication except in this small group of transgender women and cis males who take a ton of estrogen with high inflammation is what is left and we are going after it. According to Dr. J, it is in the wheelhouse of what ll can do. The Glioblastoma Multiform trial is also promising though.
There are more reasons why the hold was a blessing, but the main thing is, CYDY knows how to put together the necessary documents in the proper format now and such an occurrence won't happen again.
all the data that we wanted the FDA to look at, they halve seen as a result of the hold.
even now, in getting this subsequent hold lifted, the FDA even requested to see NASH's data so that they can appreciate leronlimab's anti-inflammatory and immune de-activating effects. They would not have looked at NASH otherwise.
The BLA was practically re-written as a result of the hold and if MDR was still an unmet need, we could have submitted it almost immediately and since they lifted the hold, they would have to approve, since it was good enough to get the hold lifted.
Without the hold, CYDY would now be spinning its wheels, not knowing what to pursue, all HIV is no longer an indication except in this small group of transgender women and cis males who take a ton of estrogen with high inflammation is what is left and we are going after it. According to Dr. J, it is in the wheelhouse of what ll can do. The Glioblastoma Multiform trial is also promising though.
There are more reasons why the hold was a blessing, but the main thing is, CYDY knows how to put together the necessary documents in the proper format now and such an occurrence won't happen again.
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