RE: Clinical Hold17 Aug 2023 09:48
Stu / HH - neither of you know the answer, so stop claiming more insight. Vlad's comment on that before getting the detailed FDA letter was that he didn't believe it was going to be necessary given what they were changing, but that was just his view and he didn't know. I take the CEO on face value on this and we haven't heard a scooby to suggest otherwise. Dare I suggest we may even only hear whether it's required in the next response from the FDA...hopefully not, I'd rather we are actively engaged with them on the solution, so know there asks, but we don't know at the moment.
On CDX - I maintain my view - we have limited capital. Don't spend a penny on it until we have spare dosh...unless it's bringing in a partner to carry the cost, or helping it being sold.
On CBR - I'll balls this explanation up a bit, but from what I remember, in vivo vs vitro...the step to vivo may have required HEMO having access to animals...I know there was a comment from Vlad that that had recently been resolved (he named the university / lab or something like that that had given them access)...but there's also something inconsistent in my memory as the horrible viruses they are testing against are all in secure / special clearance labs, so I assume they'd already have the access to animals. Unless of course they're testing with simpler viruses in vivo first...that may make sense based on the bits I remember.