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You may be right but if NWBO requested and then received a rapid review timeline from the MHRA and they did not PR that, that would be pretty stupid in my book.
Hopefully, it's because of a well deserved vacation.
Not PRing that they got accelerated review will be even worse. You need to get the word out there.
As L-T longs, I know we know that but does the average investor who when looking to see where to invest their money know that? More often than not, no. That's one of the reasons I see a rapid review PR as important. An average investor looking to invest in NWBO will not know what we know.
I've been in a few biotechs that submitted applications to the FDA, and it was always important to know that the FDA accepted the application which is what you're saying when we got the submittal PR. Fine. But accordingly, investors also want to know whether they were in an accelerated approval timelime such as a Priority Review where FDA reviews an application within six months, compared to 10 months under standard review. That's what I would like to know here i.e. whether we're in an accelerated review process w the MHRA review. I don't know what to tell you but that's important to an investor even to a long-time NWBO long like myself.
Yes, but we don't know if it's the quicker 150 day rapid review clock or less accelerated time table. If not rapid review it will take longer.
Right now we don't know if they will get a review under the MHRA's rapid 150-day review pathway.
Great point NotSure2. You can debate all you want whether we'll get another PR about validation but if they get MHRA's rapid 150-day review pathway, there is no debate that should be PR'd, at least IMO. I thought I remember reading in these recent discussions on the board about whether we'll get a validation PR that DI was non-committal about it (but I agree w Flipper et al that DI would categorize it as a milestone). Maybe, that's where the dividing line is i.e. on whether they get MHRA's rapid pathway. IMO, rapid pathway or not, they should PR as much as possible. A validation PR may not affect the share price but it will affect our mental attitude is the way I see it; a MHRA's rapid 150-day review pathway PR even more so and that probably would be impactful to the SP.
Ironic...and funny.
Yes, they would just inspect the labs, pre-clinical labs. It's under Good Laboratory Practice guidance. They have dedicated auditing teams that do just that and I have participated in many GLP lab audits (as well as a few clinical and manufacturing labs). Anyways, if you want to believe it's something else that's fine. I just want to make others be aware of what you're stating is not what you think it is and they can can make their own judgement. I was just trying to stop you from going down some rabbit hole. And this is my last post on the subject.
It's non-clinical. Why would the spreadsheet be named "NonClinical_Labs_Inspections_List_(10-1-2000_through_9-30-2023)" From wikipedia
The name of the file that you linked is named "NonClinical_Labs_Inspections_List_(10-1-2000_through_9-30-2023)" which would infer it has nothing to do w clinical or commercial manufacturing.
Dstock, these are pre-clinical inspections. Many of the new chemical entities that are tested here don't even make it to clinical nevermind approval.
I disagree to disagree and that's final!
I would speculate we are really close but we really don’t know. We had a discussion about this earlier this month. This is what LP said at the ASM last Dec.
Right. And when Flaskworks is implemented, speculation is you multiple by ~10ish.
You know what's especially interesting about your post besides MHRA approving first? They submitted first to the MHRA just like NWBO.
Well, Ex, I think you know my shtick; Sawston will manufacture for all until expanded capacity is needed. We'll see.
Maybe so Flipper but chatgts can't hold a candle to your version of
Sorry to hear Smokey. Direct might become an option via clinical trials in the near future but in the meantime don't be afraid to do your own research. My significant other had HER2 breast cancer around 10 yrs ago and went to a MSK satellite in NJ. They recommended HER2 SOC but then recommended/insisted undergoing non-HER2 hormonal BC treatment (for an additional 5 yrs I think) which I knew took a toll on the body. Luckily, I read an apropos medical article which outlined what was SOC for the various BC treatments and I surmised that this additional treatment was unnecessary for what she had. Went and got a second opinion which agreed w what I read and went w that and she's been good ever since (and having said that I have to spit, spit spit over the left shoulder to ward off bad luck). Having said all this, my friend had throat cancer a couple of years ago and went 110% in on what the docs advised and he's been doing great but you get the point. Good luck!
PS I can see from just reading headlines the SOC for colorectal cancer is evolving so pay attention to that albeit it's probably new treatments for 3rd line therapy.
Happy Birthday! It was my significant others Bday too. Celebrated w a visit to the The Metropolitan Museum of Art, dinner, and an off Broadway play. And of course, had to walk thru Manhattan to catch all the Christmas displays which were beautiful. 14.5 miles walking in total. I'm surprised I got the energy to post this AM.
Now there's a thought. Not crazy about the thought but then I thought about the Sawston lessor, Huawei. And said to myself, Oh, that would be interesting if they're involved in pharmaceuticals, but when checking if Huawei was, the answer was no but if they were, your thought would really have been interesting.
Nope, you're not cynical at all regarding "BP foot dragging on a partnership deal". My thoughts go that way too a lot. I think buying a share of NWBO is out of the Q right now because the difference in price that the shareholders for NWBO and BP think is an accurate price is too large. I do think we can get right now (ie after submission acceptance) a deal w small upfront payments, a large share of development costs (i.e. clinical trials) w large royalties and biobuck milestone payments for each indication and region marketed except in GBM. So smaller upfront payments that BP could easily justify but would give confidence to NWBOs share price. I hope the clinical trials in new indications aren't 50/50 type deals since at this point in time that will really dilute the hell out of NWBO.
Meanwhile, DCVax-L in GBM may be a different animal. I think of it as the pilot program that's close to fruition that NWBO will have to navigate to MAA acceptance; this is where I think a holdup in a partnership will occur. I think NWBO will want significant upfront payments that BP will have a hard time justifying to its shareholders so I think that's more of a show me situation. It will probably wind up a small upfront payment, generous royalty payments and significant milestone payments that increase w sales.
All speculation but the timer has been set. 2024 will be an interesting year, no doubt.
JTORENCE, you're pooh poohing again and also being (too) picky. Last I heard Christmas is on Dec 25th and today is the 21st. It's plenty of time to add this PR as your stocking stuffer unlike your version
JTORENCE et al, stick a fork in it!!! That is, your pooh poohing.
So is there a correlation w record time to approval?
And for The Emperor of ALL Cancers? One to two months seem too long😑. Useful info. Thx.
Man, I was crossing my fingers for you guys. It would have been sad...on multiple levels.
Thanks TheFollower. It's kind of what I was thinking. It's almost a moot point since short term, I don't intend to withdraw from my Roth. Things to consider for another day but right now I got this chit ass grin on my face that for some reason I can't wipe off my face and I'll have to tend to that😁.
TheFollower, Q. Is each yearly contibution subject to the 5 year ROTH withdrawel rule penalty? I started contibuting 5 or 6 yrs ago so I want to confirm my options when NWBO hits it big 😀. Say I contributed X dollars in yrs 1, 2, 3, 4, and 5. So now say it's yr 6, Can I withdraw, w/o penalty just the funds associated w yr 1's contibution, or all 5 yrs worth of contribution? I'm pretty sure, I can withdraw just year 1 funds w/o penality but judt want to confirm w someone who seems on top of it..
Oh Yer!
Welcome to the Board, and Ihub, Ken09.
And the MHRA beat out the EMA in approving Mirati Therapeutics’ KRAS inhibitor Krazati
A 'How to' on reporting RWE. ESMO Guidance for Reporting Oncology real-World evidence (GROW)
It will be interesting to see if he gets back to you and confirm and/or provide more clarity.
This reminds me when TFF manufacturing was being discussed, a process which brought increased potency. RKmatters et al (including me and others) didn't think it would be a problem, And now w Biosimilar Development familiarity I think even less so. As a blast from the past, I'm pasting part of a post in an exchange RKmatters had w evil Voldemort (Pyrrhonian). Note - TFF manufacturing was being discussed when many were wondering if it was being used in the manufacture of DCVax-L. She finally concluded that it wasn't (it was being used to manufacture Direct) but still a relevant post.
The MHRA, FDA, and EMA are all getting more comfortable on the biosimilar review process. What were issues when biosimilars were initially being approved aren't now.