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biosectinvestor

06/28/20 9:00 PM

#292270 RE: Lykiri #292265

Interesting.
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hankmanhub

06/28/20 10:01 PM

#292276 RE: Lykiri #292265

Lykiri and Iwas, just to clarify the process in the UK a little more for those of us who know little about it, what does the UK call their equivalent to a BLA and when did NWBO start this filing? I presume that this is what you are referring to about hearing news before November in response to this filing - I assume that the RA in the UK is the MHRA?

The expected timeline for their answer for approval would be like a PDUFA date? What exactly does the NICE recommendations cover and is that from the MHRA as well, and is this something different than a plain vanilla approval?
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Doc logic

06/28/20 10:23 PM

#292278 RE: Lykiri #292265

Lykiri,

Thanks for that followup. Seems like this weekend many are connecting the dots and the excitement is building in the broader community. Best wishes.


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eagle8

06/29/20 4:25 AM

#292290 RE: Lykiri #292265


Thank you Lykiri.
Very interesting.

GLTU
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erik007tc

06/29/20 7:47 AM

#292303 RE: Lykiri #292265

Excellent Lykiri, great DD and confirmation once again!
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Kam8

06/29/20 7:57 AM

#292304 RE: Lykiri #292265

Amazing news. Thanks Lykiri
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hankmanhub

06/29/20 8:43 AM

#292319 RE: Lykiri #292265

Lykiri and Iwas, just to clarify the process in the UK a little more for those of us who know little about it, what does the UK call their equivalent to a BLA and when did NWBO start this filing? I presume that this is what you are referring to about hearing news before November in response to this filing - I assume that the RA in the UK is the MHRA?

The expected timeline for their answer for approval would be like a PDUFA date? What exactly does the NICE recommendations cover and is that from the MHRA as well, and is this something different than a plain vanilla approval?