For some reason, sometimes .. it looks like NP doesn't care of the impact of his words spoken or written towards SP, even though they are working hard to campaign.
Or maybe it is also just us looking all this under the magnifying glass, while we also know .. in the end it doesn't really matter.
So yes, 100 pts safety at least 'secured' and when 40 pts are newly enrolled for whatever, they will be done 2Q19 for BLA completion. OK, matches new timeline.
Whatever they enroll now (screening) w/ 700mg surely will be used for the new mono pivotal trial, which is currently being negotiated. Makes no sense otherwise.
I doubt FDA wants more data for new mono trial design, as they already felt in love w/ 700mg naturally - to be used in combo now.
Exactly.
Makes me smile. The previous trials used this 'warm up' and allowed them to change something in the protocol, cheap adjustment but no failure. Yes.
IMHO, the data is mature enough now and they should just run the 48 weeks maximum straight for the new monotrial. If smart and they could prove that less time is required to show efficacy or better no failure - the better. AFAIK data known already shows that past 24 weeks one could extrapolate failure.
Regardless, a mono start in 2019 could give mono approval in 2020 after combo.
Assuming the mentioned upfront cash comes in, financing of the pipeline would be secured.
Now we have another investor conference soon .. so maybe a few millions will still be raised. Not impossible and not devastating at all.
Model shows roughly $31M would be needed for 1H19, but that includes the $19M payables. So if the latter stays same, we only need $13M 1H19 before partnership.
Update model, thanks to your 51% VL-Sup reference: https://finesand.wordpress.com/2019/02/03/cyt...ion-model/
Or maybe it is also just us looking all this under the magnifying glass, while we also know .. in the end it doesn't really matter.
So yes, 100 pts safety at least 'secured' and when 40 pts are newly enrolled for whatever, they will be done 2Q19 for BLA completion. OK, matches new timeline.
Whatever they enroll now (screening) w/ 700mg surely will be used for the new mono pivotal trial, which is currently being negotiated. Makes no sense otherwise.
I doubt FDA wants more data for new mono trial design, as they already felt in love w/ 700mg naturally - to be used in combo now.
Quote:For Combo it made sense for the fda to allow the switch to 700mg. NP was asked in a CC about it, but he didn’t want to switch because he thought they would require a new trial. But the FDA is looking at it from a patient benefits perspective.
Exactly.
Quote:so similarly their idea of an induction period for 6 weeks and the start trial is just a math trick allowing them to discredit the failures during the first 6 weeks. I suspect the FDA is smart enough to notice and consider that without changing the trial design, and thus might have said don’t change the design and we will allow the old 700mg patients in the pivotal trial.
Makes me smile. The previous trials used this 'warm up' and allowed them to change something in the protocol, cheap adjustment but no failure. Yes.
IMHO, the data is mature enough now and they should just run the 48 weeks maximum straight for the new monotrial. If smart and they could prove that less time is required to show efficacy or better no failure - the better. AFAIK data known already shows that past 24 weeks one could extrapolate failure.
Regardless, a mono start in 2019 could give mono approval in 2020 after combo.
Assuming the mentioned upfront cash comes in, financing of the pipeline would be secured.
Now we have another investor conference soon .. so maybe a few millions will still be raised. Not impossible and not devastating at all.
Model shows roughly $31M would be needed for 1H19, but that includes the $19M payables. So if the latter stays same, we only need $13M 1H19 before partnership.
Update model, thanks to your 51% VL-Sup reference: https://finesand.wordpress.com/2019/02/03/cyt...ion-model/
