News Focus
News Focus
icon url

newman2021

05/19/22 11:29 AM

#476032 RE: antihama #476031

yep exactly is what my pigeon bird told me the other day. He flew all the way from UK.
icon url

Red_Right_Hand

05/19/22 11:33 AM

#476035 RE: antihama #476031

Thanks Reefrad for your feedback. I don't agree w DI that not updating CT.gov was a nothing burger. A couple of negative articles and tweets changed the narrative of the NTAS presentation. And I'm guessing we may or may not get ASCO prolly depending on whether the Journal article comes out? And I was kind of hoping we'd get a LBA reveal on May 27th even though there were good arguments that since MB was presenting at the ASCO IET a LBA wouldn't happen.

The good news I get from your discussion is that multiple pieces of good news could happen i.e Journal article, Sawston update, and perhaps BLA/MA movement.

For me the biggie is getting news on the MHRA front and perhaps Breakthrough Therapy Designation from the FDA. BTD can happen a couple of months after submitting their TLD along with other Data to the Agency. Who knows they could have had that BTD meeting awhile back since they had internal TLD in their pocket for a while and we could get a PR any day now about it. That's what I hope happens but not to confident that it will...until it happens :)



The FDA promises an answer in 60 days for BTD. At the point in time where the data was compiled sufficiently to submit a journal article, they could have asked for BTD. We don't know when that was, but the request shouldn't have to wait until the co issues the TLD statement.