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That which we focus on becomes our reality. IMO, if you can't stay positive in this investment then sell or simply put on the backburner, knowing despite the timeline frustrations, you have done your DD and it will pay in spades!
Sorry for your loss!!
If you are willing...let "us" know if there are any revelations or insight in this article. TIA
Anyone have access to JAMA?
January 20, 2022
Accelerated Approval Is Not Conditional Approval
Insights From International Expedited Approval Programs
Gautam U. Mehta, MD1; R. Angelo de Claro, MD1,2; Richard Pazdur, MD1,2
Author Affiliations
JAMA Oncol. Published online January 20, 2022. doi:10.1001/jamaoncol.2021.6854
This Viewpoint compares the US Food and Drug Administration’s accelerated approval pathway for drugs and biologics with similar programs developed by other international regulatory health authorities.
Hahaha...Good on ya friend. I'll be flying out to cheers you soon enough!!
Hahaha!!
You're the gift that keeps on giving. Good on ya, you're up to .50c per post so keep em rollin'
And yet you continue to apparently hold 500K+ shares in a Co that you feel their trial has failed??
Quite the astute investor!!
DMB2~
I am in complete agreement with ATL on the ethical consideration aspect of placebo patients.
Hi doingmybest!
Going out for a walk with my wife but will circle back to the placebo issue later
Grammar
Anti~
Most of this related to a post by Ex that stated any hold by FDA is either related to 1) safety issue 2) Ethics
I simply brought up that with an SPA, the hold or partial can have nothing to do with safety/ethics.
Reference: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167525073
Now, whether this was the case with NWBO or not...I have no idea.
GLTU
Lol...just in time! Impecable timing you will soon find out. You may want to look up information entropy in your spare time.
Here's a starter:
The concept of entropy can be applied and represented by a variable to eliminate the randomness created by the underlying security or asset, which allows the analyst to isolate the price of the derivative. In other words, entropy is used as a way to identify the best variable to define risk within a given system or financial instrument arrangement. This is usually the one that deviates the least from physical reality.
In finance, this can be represented with the use of probabilities and expected values. While the calculation itself is evolving, the purpose is clear; analysts are using the concept to find a better way to price complex financial instruments.
GLTU
Naive statement alert
I think they must enjoy seeing ALL your disparaging posts?
I mean, if they gave us more than breadcrumbs they/we wouldn't have you posting 24/7. Consider it comic relief and you fill that role quite nicely!
Thanks for your continued insight thermo!!
Special protocol assesments, or SPAs, are important for every drug company, from the tiniest fleaspeck biotechnology company all the way up to Pfizer. They are agreements between a company and the FDA that a clinical trial, if conducted as planned and successful, should produce enough data for a drug to be approved. This reassures companies that they are not going to pour $40 million into a late-stage study only to have the FDA say it did the wrong trial. SPAs also ease investor fears, helping smaller companies raise money.
Unfortunately, they are treated by FDA as confidential communications between the agency and companies. What is said to investors about the SPA is entirely up the the company.
Just another example for Ex. Protocol changes, updated SAP can ALL happen as long as the sponsor is still blinded.
The FDA removed the partial clinical hold based upon agreement on revisions to the CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines and updated futility criteria. Enrollment in the CANOVA trial may resume as determined by each participant site based on the approved protocol.
https://news.abbvie.com/news/press-releases/abbvie-announces-us-fda-lifts-partial-clinical-hold-on-phase-3-study-venetoclax-in-patients-with-multiple-myeloma-positive-for-t1114-genetic-abnormality.htm
Completley false assertion yet again!! Keep Trying
Exactly!!
And what was Ex's guess/assertion regarding approval of Provenge?
Well, needless to say he was wrong there as well. If one flings enough out there, once in a blue moon something sticks
Excellent interview with Pazdur in 18' around use of EC's/RWD and flexibilty at FDA level for I-O approval. At 14 minute mark it gets good
https://rwe.flatiron.com/video/real-world-evidence-fda
GLTA
These will be sufficient
90% : My basic thesis, trial failed
70% : We will not see any full results in H1 2022
99% : No approval in 2022
90% : Revenue under $5M in 2022
Won't it be fun to look back at these misguided assertions this year!!
Wrong Again!! Keep trying
Great post DMB2!!
Quite the journey this has been for our "little train."
GLTA
WRONG...I'm sure you're able to read the link I sent! Absolutely zero to do with safety or ethics but keep trying!!
I can certainly keep sending you more examples if you need to update your line of thinking?
Wrong again!!
I guess you know better than
https://brainstrust.org.uk/wp-content/uploads/2019/03/brainstrust-know-hows-immunotherapy-10.02.19-1.pdf
DCVax®-L can be accessed privately on a very limited compassionate-use basis under the Specials regulation in the UK
While we're at it...what did you say the capacity for Sawston was? I recall 4-6 patients per month, correct?
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-mhra-approval-of-license-for-gmp-manufacturing-at-sawston-uk-facility-301449083.html
The Company anticipates that Phase 1A alone will be able to manufacture DCVax-L products for 45-50 patients per month, or 450-500 patients per year
Incorrect statement yet again Ex:
IMHO they expected the journal to be out by the time MB was to speak at the conference.
Let's hope there are not too many more delays ahead. The road the can has been getting kicked down is only a few hundred feet now!!
GLTA
Even these BS Spinners won't be able to refute the trial data about to come out in the journal publication.
and yet you will be parading around the board in no time talking about how big your position was. On time, all the time...kudos
GLTA
Sell already and put yourself out of your own misery!!
Sojourner55~
Are the springs coiled yet??
GLTA
The gift that keeps on giving for sure
Thanks Flip and I know we are both truth seekers in spite of occasionally getting it wrong
Soon, I hope we can reach out to Pyrrhonian/Steve, buy him a pizza and nice bottle of grape nectar
Sent from my living room while watching golf at Kapalua Plantation Course
My "buyin" happened when the EU updated their registry and I had a better understanding that there is a 30 day window with the FDA to object.. If they say nothing there is no rejection.
I am also ok stating publicly that I was wrong about something or after further DD, changed my opinion and thinking. Something many on this board are unable to do.
If you go far enough back you will also see my Hx of "highs-lows" with NWBO. I am quite comfortable currently with my position and opinions on NWBO and where we/they are at. All investors need to do what they are comfortable with base on risk assessment.
As for me, I continue to slowly add to my position as I anticipate news coming very very soon.
GLTA