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Your stock is going to zero,... Sorry. Not my fault.
JMHO
LOLOLOLOL
LP selling shares like lemonade
Gonna be a lot of heartache here soon
IMHO
No mention means working days.... as in everything else.
If it was NOT working days, you would have already gotten an 80 ( calendar day) decision... duuuh It is already 117 CALENDAR DAYS from submission, and NO response yet. What does that tell you? It's WORKING DAYS!
Pay attention, or call L Goldman and ask him!?
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment ***********phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days. **********
Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. Assessment in phase-I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings. Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.
READ READ READ!
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
"Dave Innes
10:50?AM (2 minutes ago)
to me
Will let everyone know when we have selected a date.
Dave "
LOLOLOLOLOLOLOLOLOL
It is therefore disappointing that due to key methodological limitations, the DCVax-L trial ultimately failed to provide sound conclusions about the potential efficacy of such approach for patients with glioblastoma.
https://pubmed.ncbi.nlm.nih.gov/37012085/
Sure did... Ignorance is not bliss
Barely holding 50 cents
More like GAME OVER!
MTD granted and MHRA rejection
So we are 116 days in... Where is the 80 day Phase 1 assessment?
Rejected ? LP hiding it? Just going off your eternal wisdom.... I'll wait. Was there an RFI or just an outright rejection?
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed ******80 days after the clock starts.****** Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.
Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. Assessment in phase-I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings. Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
Basic requirements for IRP applications
All IRP applications must meet the following basic application criteria:
The company must be established in the UK, i.e. Great Britain or Northern Ireland, or in the EU/EEA.
Is NWBO headquartered in Great Britain or Northern Ireland, and do they qualify for IRP?
Please revert to remedial reading
Re read your own link that you posted, dummy.
Location of Applicants
The Applicant/marketing authorisation holder (MAH) must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA. It is anticipated that the MAH for an application via the IRP is the same company or belongs to the same (legal) group of companies as the MAH for the RR procedure. This is to ensure that the MAH can fulfil the submission requirements as well as all their legal obligations, such as the obligations stated in Regulations 74 and 75 of the Human Medicines Regulations 2012 (HMRs).
Provided an Applicant can demonstrate and provide written assurance that all the legal obligations can be met at submission, during the assessment process and throughout the life of the MA,
And then read THIS, or better yet, have an adult read it to you...
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
If stupid was money, some on this board would be Billionaires
IRP will be open to applicants that have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators (RRs)
Plus , if your idiotic analysis is correct, we have well passed the 80 day phase 1 assessment!
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.
Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. Assessment in phase-I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings. Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.
A little bit of knowledge is a dangerous thing....
Does that mean MHRA already rejected it?
Location of Applicants
The Applicant/marketing authorisation holder (MAH) must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA. It is anticipated that the MAH for an application via the IRP is the same company or belongs to the same (legal) group of companies as the MAH for the RR procedure. This is to ensure that the MAH can fulfil the submission requirements as well as all their legal obligations, such as the obligations stated in Regulations 74 and 75 of the Human Medicines Regulations 2012 (HMRs).
Provided an Applicant can demonstrate and provide written assurance that all the legal obligations can be met at submission, during the assessment process and throughout the life of the MA, it may be possible to accept applications from third parties.
Northwest Biotherapeutics
Headquarters
4800 Montgomery Lane, Suite 800
Bethesda, MD 20814
Phone: 240-497-9024
I can answer that.... Yes...
You still can't differentiate between business days and calendar days..., and you still haven't read my MHRA guideline link...
Get a clue friend...
On the contrary, the price is 90% too High
Are you seriously posting 8 year old crap?
<<< The accepted PIP calls for a completion date of summer 2028. >>>
How can they issue approval 4 years in advance of that? And who will be paying for those trials? $100 million, or more?
From what I hear, ( from a former regulator) NWBO did NOT get a waiver... PIP trials are absolutely required for any chance of approval.. I could be wrong.
That being said, the phase 1 80 business day assessment is just about up.. We will soon have guidance.
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.
Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. Assessment in phase-I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings. Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#assessment
Ex... Any truth to this? In your opinion.
“No matter what anybody says, NWBO cannot get approval until they run the pediatric trials. This is from the EMA - same rules apply MHRA
"All applications for marketing authorization for new medicines in the EU must include the results of studies as described in an agreed pediatric investigation plan, unless the medicine is exempt because of a deferral or waiver."
NWBO submitted a SAP for pediatric trials, which has been accepted. But until they run - or start to collect enough data to make a case - they are dead in the water. No matter what, they have to run pediatric trials .
<<< &375 million >>>
Is that a Monopoly board game currency denomination? Never saw that one before.... hmmm
Any data on that? It's an interesting observation.
And you haven't learned ANYTHING!
Keep smoking what you're smoking.... it's working
Looks like insiders have been selling since 2015 and there hasn't been a purchase since 2015.... The current holders have all been gifted or awarded the shares.... Yikes. 16 people own almost 10% of all the shares. Almost 111,000,000 shares and I don't think that counts their awarded warrants and options.. I would love some more clarity on this. Ex, LC, IC, anyone?
Net Number of Insiders Buying (Rank) "0" ( zero)
https://fintel.io/n/us/nwbo
DCVAX is NOT up for approval for all solid cancers, as a mono therapy, or anything else but the failed PIII trial which was inconclusive, that they are presenting to MHRA. PERIOD.. People,... Please stop all the other fantastical dreams of replacing SOC! It's not even funny anymore. It's a one in a million Hail Mary pass, and most likely will not get approval.. Put that into your investment analysis. IMHO
>>From the trials at UCLA we know that Poly-ICLC and/or Keytruda greatly improve GBM survival,
UCLA owns that licensing as far as my research tells me. LL and Prins worked there at the time of development
It is therefore disappointing that due to key methodological limitations, the DCVax-L trial ultimately failed to provide sound conclusions about the potential efficacy of such approach for patients with glioblastoma.
https://pubmed.ncbi.nlm.nih.gov/37012085/
Institutional Shares (Long) 533,820 - 0.04% (ex 13D/G) - change of -2.57MM shares -82.82% MRQ
Is that why the whole street and every institution has abandoned and is still abandoning this stock many years later? C'mon man! Only a few fools are left holding this bag.
Scientists also disagree with you.
Autologous tumor lysate-loaded dendritic cell vaccination (DCVax-L) in glioblastoma: Breakthrough or fata morgana? Preusser, 2023
"An initial report on the trial in 2018 reported only on the combined overall survival (OS) data of both study arms and failed to report on PFS, the primary study endpoint. The argument for not publishing the primary endpoint was an ambiguous statement about an expert panel being required because of the complex determination of progression.
Now, more than four years later, a second report is available, which is surprisingly named “A Phase 3 Prospective Externally Controlled Cohort Trial”. This is a remarkable title, as the investigators have re-analyzed the OS data of the study against published external controls and present this as a prospective trial. It is obvious, however, that this is not a prospective analysis but a post hoc retrospective analysis: the investigators had seen the data, both of their own study and of the cohorts taken for comparison and then decided to go ahead with cross-trial comparisons."
Great news for GMB patients.
Nobody cares
The only thing that got disrupted was the failed trial that the FDA halted... The one where a placebo had better results than DCVAX in PFS, the original end point that was changed.. lol
I'd like some of what you're smoking...
DCVAX L and DCVAX are both failed products.
EOM
IOM
$$$$$$$
only on a 1:100 reverse split... maybe!
I disagree... If that was true, LP would be Chairperson of that club and they'd all own a piece of Advent!!!!
IMHO
NO QUESTION!!!!
I humbly disagree.
MMs don't do that kind of stuff, they facilitate trades, long or short... . The large blocks the insiders are selling are pre arranged when they have the buyers for the shares.. That's why it doesn't trade like a normal stock. It goes silent at times and then BOOM... 80,000 share block and a corresponding increase in outst. shares.
Looks like they wait for the pumping machine ( with their crazy approval talk and $20 Billion buy out posts) is working so far. In my opinion, dumb, greedy retail buyers are sucking all the stock up... Institutions are almost completely out, no BP interest anywhere in sight, just dreamers thinking they found the pot of gold at the end of a rainbow. So sad to see. All real and serious investors have already abandoned this stock. Any increase in SP will be a miracle.
Again, these are just my opinions..
I'm amazed that she has managed to keep this stock at the $600M market cap level for this long... I think $60 million is overvalued. Hats off to this magnificent defiance of gravity.
Perhaps Austin Powers is also a consideration? Yeaaaaa Baby.
Any relation to LP, LP or LL? lol
He was only off by tens of millions of dollars