Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I’d forgotten about that hyperactive DC. :)
Isn’t it? But as I’ve explained, I believe they’ve gone with that date as it’s the more conservative date to go by, and not because they’ve been told that by MhRA… thus, absolutely no need for a rigid disclosure.
Wow… I hadn’t noticed that. Excellent! :)
Those recurrent GBM results really are remarkable. I am grateful that the data from the control group who crossed over has not been set aside due to psPD, but rather has been used to prove efficacy in rGBM. It’s really quite brilliant. :)
Isn’t that the truth?! They regularly point out how LP is so skilled at building CMOs, yet somehow, none of that skill ever crosses over for them (the shorts) to building a biotech company? Not particularly logical in their thinking, are they? :)
$100 mill x 5 = they probably would take it. There’s a lot they could do with that much money, and all without dilution. But I agree… it would very likely be a no go at $100 mill.
Hmmm... interesting.
Right into my ear, and others.
Wow... that post of mine you responded to dates back to 2014. :)
Well, if MHRA is trying to stick by the 150 day + 60 (=210) clock off time line, October 3 is 210 days following the March 7th second validation, which I've heard is the one NWBO believes counted as the validation date, not Jan 27, despite the letter Sparky received.
That said, I'm just waiting (trying to be patient) here like so many other longs. Fall starts in a few days, so hopefully, the MHRA MAA answer will come sometime during the Autumn equinox. :)
Well at least we know then that the price won’t drop past $0.304 until the MMs decide to go through you. :)
Agreed... I've been unable to get to the bottom of the reasoning of why anyone would post negative (let alone positive) 24/7/365 on this board and not be invested in some way. It boggles the mind.
But I sense that you’ve spent far longer on this board than you intended. Has the time gotten away from you? Has the story gotten only stronger for you, too?
And we’re closer to approval today than we were “over two years ago.”
No, for ten years, this has been a great opportunity to buy.
You can only delete posts that are less than 48 hours old. So as usual, you are incorrect. :)
That likely means feeding him information beforehand, or his hedge fund buddies... and that's illegal.
Glad to see you're back in with us again. Hopefully this time, you're in for awhile and are able to make some good profits for a charity (presuming that's still your goal?).
:)
Thanks, yes, all good points. :)
I do think that an MHRA MAA approval will help with an FDA MA; which is one important reason I suspect they are waiting to submit.
Interesting… from your link:
You’re right… he does not appear to be the same guy. My mistake. :)
Interesting, seeing as immunotherapies typically work best with melanoma, which is why so many immunotherapy treatments start with melanoma trials, and of course, not GBM.
Excellent! Thanks for delving more into the details as to what this latest MHRA MIA means in the ongoing MAA process. :)
There was a Mike Taylor on the Big Biz show Les often makes an appearance on a couple of weeks ago who indicated on the episode that he’s working with Northwest. We were all speculating who Mike Taylor was and what company he might be with, and someone else had mentioned to me that he might be with Critical Mass. But the picture doesn’t at all match the Mike Taylor who was on the Big Biz show, discussing NWBO.
Here's a link to last year's MIA posting.
https://cms.mhra.gov.uk/mhra/mia/uk-miaimp-54923
Please note, Legal Authorization reads:
I haven’t spoken with him for awhile, but someone else I know has, and he’s fine, just super busy.
You reference the FDA guidance on the use of external controls for clinical trials dated February 2023 and titled: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Guidance for Industry (which we should note is still a draft guidance).
https://www.fda.gov/media/164960/download
But when the Statistical Analysis Plan (SAP) for the External Control Arm (ECA) was being designed, this guidance had not been published by FDA. As noted by the company in their 2018 Annual Report (dated April 2, 2019) on page 2:
True… a good start would be to invest in the companies she represents.
I definitely agree... it was mentioned, in connection with a brain tumor. Obviously the writers of the scene weren't as familiar with DCVax as we are, but there is no denying, it was mentioned as the treatment the man in the scene had turned to.
Of course… it’s dialogue from a popular HBO show.
Transcribing the fuller conversation of HBO’s Industry, Season 3, Episode 5, regarding the DCVax conversation:
Sorry... I was responding to Doc Logic re: whether I knew that Direct had initially began as a mouse study... which I obviously did.
It's still a great PR, and IMO, Direct will be amazingly helpful, despite what those who aren't invested but post 24/7/365 state often.
You are right! I remember…
$NWBO's DCVax doesn't involve mice but still nice to see it mentioned this evening on @HBO's Industry. pic.twitter.com/xhqwG9jIJT
— autologous assassin 🇺🇸 🇺🇦 🇮🇱 (@flaskworks) September 9, 2024