Yes they are talking approval. NP hit on this last time he spoke. They will most likely file the BLA this summer.
NP said specifically during DrBeen show the other night that it would take six months for the FDA to get back to them on the BLA, bringing us to the end of the year. That’s not a surprise if people have been listing lately. THIS IS NOT NEW !! Personally I’ll just be happy if the BLA is good by the end of Q3. Not directed at you but let’s all just hope that it gets done within the next few months.
I personally thought this was a pretty decent CC and NP sounded pretty good today. I like how he had people speak for specific topics and everyone seemed very confident.
Also NASH is moving along very well and I personally look forward to this around Q4 for possible interim readout. I’m actually shocked that we are even on track for NASH. I believe Kelly is doing a good job with this. Anyone remember enrollment numbers vs the numbers needed ?
Another question.... What will it take for BTD for the cancer basket trial ? I’m not very up to speed on this, but Kelly was saying people in the trial were doing very well after several months and it seemed very promising.
TNBC I’m kinda wondering if enrollment slowed down due to no interest or we aren’t showing results ? Is COVID ‘slowing things down’, maybe cover story for we aren’t getting the results we wanted? I really don’t think that’s the case but I would like more answers on this.
Overall very good call.
NP said specifically during DrBeen show the other night that it would take six months for the FDA to get back to them on the BLA, bringing us to the end of the year. That’s not a surprise if people have been listing lately. THIS IS NOT NEW !! Personally I’ll just be happy if the BLA is good by the end of Q3. Not directed at you but let’s all just hope that it gets done within the next few months.
I personally thought this was a pretty decent CC and NP sounded pretty good today. I like how he had people speak for specific topics and everyone seemed very confident.
Also NASH is moving along very well and I personally look forward to this around Q4 for possible interim readout. I’m actually shocked that we are even on track for NASH. I believe Kelly is doing a good job with this. Anyone remember enrollment numbers vs the numbers needed ?
Another question.... What will it take for BTD for the cancer basket trial ? I’m not very up to speed on this, but Kelly was saying people in the trial were doing very well after several months and it seemed very promising.
TNBC I’m kinda wondering if enrollment slowed down due to no interest or we aren’t showing results ? Is COVID ‘slowing things down’, maybe cover story for we aren’t getting the results we wanted? I really don’t think that’s the case but I would like more answers on this.
Overall very good call.
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