Several take homes from the Cantor Global HCC
First kudos to analyst Alethia Young in asking pertinent Qs in this fireside chat format. I remember her in 2013 when she hosted a CC for Deutsche Bank. Back then she was asking some pertinent Qs on apaziquone but couldn’t pronounce it correctly and was getting flake from poster Candide while I was defending her.
So the big take home for me was removing this black cloud of not presenting Zenith20 cohort 1 interim top line data prior to the 4th Q CC since you’ve seen many companies do it. You can’t help but think, especially w the bad news we heard over the past year, what is wrong. I was so concerned I sent them an email voicing that concern but they ignored it. I was so annoyed that they didn’t address it at the 4th Q CC that I said I wasn’t going to post till TL came out but changed my mind after a few days and started posting again. At the Morgan Stanley CC, they briefly mentioned why but being so brief it really didn’t remove that black cloud from my thoughts. And if this long was thinking ‘what are they hiding’ what were the naysayers thinking? To make a long story short, as explained by JT and FL, they are blinded to the data (scans) that will be determined by the Central Imaging Lab, analyzed by specialized vendors (i.e. statisticians etc) and that will be reviewed by an expert panel that will issue a brief report to Spectrum indicating whether they met the endpoints (ORR, 6m duration and safety) which will be then PR’d by Spectrum. After the PR, Spectrum will drill down into the data and present the full data set at an upcoming Conference. Considering that they have 6m data for the last patient since around the middle of July, I think the PR will occur within the next month or so.
We’ve heard the other stuff that they talked about regarding pozi in other CCs/PRs such as why the results may be better than the MDACC trial but it’s worth listening to again.
The other confirmation we heard is that the Rolontis filing will occur this Q noting that they had a very positive meeting w the agency where “they walked us through” the CMC section. And they are “checking and rechecking and a lot of experts are looking at it”.
A very positive CC w JT and FL showing confidence and fluid in their discussions. Fireside chats are so much better than the dog and pony show variety where they just go over a power point presentation.
