Yes flakes your right , I wonder how he is processing that but at this point him and his team are actively planning to resubmit focusing on specific issues so at least they know where the weakness is and suggest they will do their best to right the ship
On appeal no new data can be submitted, only the data previously considered.
The hope is the new rapporteur and partner will have a more open mind to a treatment that clearly leaves the long held bias toward anti-amyloid therapies as the target.
The 30 member CHMP is spoon fed the opinion of the two rapporteurs and I suspect tend to defer to them since they have spent so much time understanding the data. So the results are mostly a result of two people.
Two fresh sets of eyes and priorities can change the result. Just like it did when the two Mabs were rejected then passed on appeal.
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