Brian Uherek blijft interessante dingen zeggen:
Catching up today (I was busy with other matters yesterday) - I didn’t realize the plan is to co-administer Artiva’s product with AFM13 separately (not infused together as one AFM13-NK).
I definitely don’t like this & most likely will lead to a lengthy new trial.
Can’t believe that Affimed continues to shoot themselves in the foot!
Unbelievable!
Reactie van machbaer:
I disagree: if administered separately they can use the information that both reagents on their own have been shown to be safe. I never had concerns that pre-complexed vs co-administration makes a difference. I guess they chose the variant which is most likely to convince FDA.
Brian:
It’s totally different, there will be a lengthy new trial, neither Affimed or Artiva have the clinical experience to make such outlandish assumptions.
I repeat.. unbelievable ??
Machbaer:
I can’t comment on how this impacts FDA decisions. I can comment on the probability how the different administration routes will impact the efficacy and I am very optimistic that it makes no difference.
Brian:
Show me your probability model, cut the BS, this combination will require a lengthy new trial first to show safety, second to show efficacy.
Listening to the call for the first time, Arndt talking about mouse models and Andreas saying a dose escalation study won’t be needed, UNBELIEVABLE.
Someone wake me up from this surreal nightmare.
Cantor analyst asking about their regulatory experience (I can see where this is going - downgrade likely)
They can’t go into more detail regarding their experience, can you believe it? Incredible
Heb the call nog niet beluisterd, maar kan me goed voorstellen hoe naïef Hoess en de zijnen hierover denken. Benieuwd hoe dit verdergaat, maar eerlijk gezegd verwacht ik de komende tijd eerder lagere koersen dan hogere.