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Maybe this time will be different.
The Truth and The Way!!
(a lamp unto my feet)
We are in need of a new sock toss!!
Totally agree...thx Doc!!
Many did not realize the significance of this publication. To me it speaks volumes as the where DCVax will first be approved. https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext#%20
Annal of Oncology is the official journal of the ESMO
https://www.esmo.org/meetings/esmo-virtual-advanced-course-on-cancer-vaccines-and-cellular-immunotherapy-2022
Yep yep and Yep!!
They can make a grown man cry
No that's some funny $hit!!
Truly, the gift that keeps on giving
Care to delve into recent FDA changes pertaining to use of EC's/RWD as it relates to regulatory approval?
Lol...Completely uniformed, nonsensical, prevarication
In the grand scheme of things Flip, consider those that actually deal with the $hitty disease on a personal level.
Look at the long fight that Matt Henkel (and many others) put up and all that he went through and that his widow and kids are still goinging through.
I truly believe that this is a battle. It's a battle for patients, their families/loved ones and unfortunately, it's a battle on this side as well.
Above anybody, you have done your DD and need to trust ALL that you have immersed yourself in and had the patience to share with others.
This is a therapy that saves lives and is a game changer...it's that simple IMO. If it wasn't, it wouldn't be so damn hard!!
GLTU
Still keep in touch with the crazy SOB...he's got a great heart!!
Good ridance!!
BTW, did your friend in dire need of cancer treatment get ahold of NWBO?
Was CLDX data hyped?
Precisely!!
I expect volume to pick up dramatically throughout the day...we shall see
So announcing the production of the cancer vaccine that people desperately need such as your friend is now considered a pump?
You may want to let you friend know who sounds like she only has a little time left that the treatment you are recommending is a "scam and pump."
She's gotta be happy she has you in her corner!!
Thanks!!
Perhaps many pieces on the chess board are in motion as NWBO gets ready to release data from their trial.
Historically, the Food and Drug Administration’s (FDA) review divisions showed limited interest in industry RWE generation activities outside of restrictive policy statements cautioning companies against using RWE to attempt to substantiate marketing claims. This was in part because of doubts about whether such studies could meet the “adequate and well controlled studies” standard required to support prescription drug or biologic product safety or efficacy claims., The 21st Century Cures Act of 2016 offered much needed clarity to the disused Food and Drug Administration Modernization Act (FDAMA) sections governing pharmacoeconomic information relying on RWE, and also led FDA to issue guidance to industry regarding how RWE and real-world data (RWD) more broadly could be used for new or supplemental drug approvals. Moreover, use of RWE is now increasingly a focus in accelerating confirmation of the effectiveness of products approved under the accelerated approval framework for drugs and biologics.
In a nutshell, with the RTOR, the sponsors have the opportunity to anticipate the FDA results from the pivotal study(ies) as soon as they are available (soon after database lock) and therefore, have an earlier engagement with the agency. The full submission package can be simultaneously prepared and later submitted, with the hope to “anticipate” market approval (“Although RTOR does not guarantee an action date prior to the PDUFA date, three out of the four cases described were approved months earlier than the PDUFA date”). As of April 2020, RTOR was used to support the submission and review drug approvals for 20 oncology applications[4,5] .
According to a recent publication by the Project Orbis partnership, the program received 60 oncology marketing applications in the first year, resulting in 38 approvals internationally (including eight approvals by Health Canada). All of the applications met the FDA criteria for priority review, i.e. the drug is intended to treat a serious condition and if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of the serious condition. Based on the data analyzed, the median time-to-approval was similar between the FDA and other Project Orbis partners, and the gap between submission to the FDA and other partners was only 0.6 months.
Lol..whatever makes you more comfortable. You'll find community with Ex and AVII.
Big Hat No Cattle
Again, very well thought out articulate post!!
Thx for your efforts
100% correct!! Ex simply doesn't understand this process
Makes total sense and so very articulately put. Evident you have done all your DD to come to this conclusion.
Appreciate the wisdom you exude!!
When you listen to the video Senti posted, focus on what Wes discussed at 18:15 mark. "If they drive you stock to zero (sprial into debt til you die) and can kill your Company/Technology, they never have to cover the illegal stock certificates. This is exactly what happened to NWBO.
Somehow, someway, Linda Powers who some here refer to as a scam artist was able to keep the Company afloat (thanks to many friendlies who believed in this DCVax/NWBO).
When ALL is revealed I think LP will be regarded as the true Phoenix Rising from the Ashes.
Based on conversations I had with Wes, what NWBO had to decide on was...do they go after bad guys, distract away from task at hand (completing clinical trial) and possible enter into a very expensive and long process of going after bad guys. In spite of what might be viewed as clear cut evidence revealing illegal manipulation, these cases are not by any means a slam dunk.
Obviously NWBO decidede to "go dark" and focus on finishing their clinical trial. I personally think this was the best option and here were are...at the end of the trial waiting for TLD. Had they gone after bad guys back in 2016/2017 I truly don't believe the Company would still be here.
I was told there would be a time that ALL criminal activity would be revealed and that is still my hope!!
GLTA
FYI...there have been death threats related to this very case
Had MANY conversations with Wes back in the day. Great guy and was more than accessible to talk with.
Not sure where things ended up and where they are now but Wes certainly felt he had a very strong case on the illegal manipulation that was happening with NWBO.
Thx for posting Senti!!
Good riddance...Cya
They must be inducting the activation of immature monocytes with grapefruit juice. Sir P gave me his word on this
Here is the patent application documentation. Note the listed inventors for the combo patent:
— Joan Lappin CFA (@joanlappin) February 10, 2022
Inventors
BOSCH, Marnix, Leo
GANJEI, James, Kelly
POWERS, Linda, F.
LIAU, Linda, M.
PRINS, Robert, M.
https://t.co/s8P6lZ2M8M
Powers has worn many hats on this road to NWBO glory.
My thoughts and prayers are with you and your family Gary!!
PDUFA VII performance goals include a plan for the Center for Biologics Evaluation and Research (CBER) to have a modernization roadmap completed by the end of FY 2022, with an eye to adopting new data management tools and technologies. New draft guidances are also planned to support sponsors in the development of novel approaches in the realm of cell and gene therapy.
The timely reauthorization of PDUFA will allow FDA and biopharmaceutical companies to build on the incredible strides made during the previous PDUFA cycle. New developments in medical and fundamental science – including immunotherapies and cell and gene therapies – hold the promise of treating debilitating diseases such as cancer, diabetes and many rare disorders. Fulfilling this promise depends on a modern regulatory framework that PDUFA facilitates and that can serve patients by providing timely, science-based regulatory decisions.
No later than 3/25/22 but what the hell do I know, I've been wrong on NWBO timelines for the past 8+yrs
Sometimes these feel like "ground rounds."
I'm not going anywhere Been here since 2013 and certianly not leaving until we get TLD and approvals!!
It's disgustingly sad!! Most other promising Biotechs at this stage would be easily in the $4-6 range at a minimum.
This is a culmination of manipulation, toxic financing deals in the past, poor and misguided communication from the Co itself and simply a lack of understanding of what NWBO has had to embark upon and the platform that they have. All the hype has been on CAR T/CI's and no one gave dendritic cell therapy the time of day.