News Focus
News Focus
icon url

FeMike

07/03/25 4:15 PM

#774074 RE: manibiotech #774072

No I’m pretty sure it’s always been just “other regulators”.
icon url

manibiotech

07/03/25 4:25 PM

#774076 RE: manibiotech #774072

Ok this is from ASM transcript posted by hyperopia in July 24

"

Of course we are anxious to submit applications for approval in other countries. We're very happy to be going through our first process in the UK, because they have the fastest process of any that we know of. And it's been really great, but, of course, we want to get start, getting applications put together, and that'll be another thing that we'll be working on during this period, and getting those prepared and submitted. We have a partial head start on them because one big component of the application anywhere, is the clinical study report, which is a ginormous document that has the 20 years of efficacy and safety data from every program that's ever been done in DCVax, even programs other than brain cancer. So, we have a partial head start, but applications in other countries will be important."

So you are telling me that a reasonable person would deduce by this language that FDA is obviously excluded . Then more power to you.