Also they are proposing to extend the study out to 404 days instead of just day 56 or day 128.
Yes but Mozz, we want a readout sooooner not later! PAR are telling us that it is extended, is more time I gotta wait!
Yes but they are doing this for a very valid reason.....to show the durational aspect ...you show signs that this drug effect LASTS that long and that means higher penetration rates and very importantly, better reimbursement rates. This all has knock on positive effects, think also deal size/magnitude potentially.
As if that's not enough, we get an interim analysis readout...so we will still get news flow potentially inbetween. Something like what we got for 008. ie 6 m and 12 m.
I like it
Now FDA just have to sanction it!
DYOR important
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