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The predictions are the highest price we get to next week under the
the 3 variables .
I`m simply talking about price action next week .
Presentation About Phase 3 Trial of DCVax®-L for Glioblastoma To Be Made At New York
Academy Of Sciences PR Newswire BETHESDA, Md., May 4, 2022 BETHESDA, Md., May 4, 2022
IF IF IF ... Linda L cancels the appearance it would mean one thing..
....we`ve been bought ..
We need end points on the FDA clinicaltrials.gov site updated ...
$1.48 today
$14.80 this time next week .
Merck & Co. Receives EU Approval for Cancer Immunotherapy
(MT Newswires)
Merck & Co. (MRK.PA) said Friday it received approval from the European Commission for Keytruda to be used for five different types of cancer.
The approval covers the use of the drug as monotherapy for the treatment of microsatellite instability-high or deficient mismatch repair tumors in adults with colorectal, endometrial, gastric, small intestine or biliary cancer.
As such, Keytruda may be marketed in all 27 members of the European Union plus Iceland, Lichtenstein, Norway and Northern Ireland.
-0- Apr/29/2022 14:21 GMT
Great summary , that post alone is worth 20c on todays share price !.. Thanks
AEK....its worthless data, tells us next to nothing ...
12 Months NWBO vs XBI
XBI -54.3%
NWBO - 40.1%
...so a kind of party trick JS Bach would do to amuse an audience was
he`d sit at the organ and ad lib a short piece of music maybe 32 bars long.
Either side of him would be two people both obviously would have perfect pitch as they wound anotate precisely what Bach had played.
They would then take the annotated music turn it upside down, someone else would then play it and it would be exactly the same as Bach had originally played....Remember treble clef, base clef and foot pedals ... if you`ve ever played a musical instrument you`ll understand how simply staggering this is in its mathematical complexity.
...you need to complete the trio .with... Aleksandr Solzhenitsyn and of course nestling on the top of the three is
Shakespeare
Tolstoy
Dostoevsky
Solzhenitsyn
Kind of like :
Bach
Beethoven
Mozart
Wagner
(Roche) New cancer immunotherapy fails in
first Roche trial
https://www.reuters.com/business/healthcare-pharmaceuticals/roche-last-stage-trial-lung-cancer-treatment-fails-2022-03-30/?taid=62444e7ab56bf00001757acb&utm_campaign=trueAnthem:+Trending+Content&utm_medium=trueAnthem&utm_source=twitter
Doc Logic, read my post again `within the first 3-5 trading sessions `...
$4.50 90%
$7.50 60%
$10.50 45%
Within 3-5 trading sessions following TLD
If MHRA application announcement is made at the same time add 10% to those percentages
$4.50 90%
$7.50 60%
$10.50 45%
Within 3-5 trading sessions following TLD
If MHRA application announcement is made at the same time add 10% to those percentages
Northwest Biotherapeutics Board Sued Over $41 Million ‘True-Up’
Thursday, March 24, 2022 05:33 PM
By Mike Leonard
COURT: Del. Ch.
TRACK DOCKET: No. 2022-0259 (Bloomberg Law Subscription)
JUDGE: J. Travis Laster (Bloomberg Law Subscription)
COMPANY INFO: Northwest Biotherapeutics Inc. (Bloomberg Law Subscription)
(Bloomberg Law) --A Northwest Biotherapeutics Inc. investor sued members of its board in Delaware, claiming they gave themselves nearly $41 million in stock options in an “unprecedented and indefensible” effort to offset the dilutive effects of a financing transaciton that caused them “absolutely no economic harm.”
The lawsuit, made public Wednesday, alleges a “gross abuse” of fiduciary power by the directors who engineered the “true-up” deal after issuing equity on terms that equally diluted every stockholder while increasing the company’s overall value.
The board members and general counsel, who also participated in the true-up, had no right “to own a specific percentage of the company’s common stock,” according to the complaint filed in Delaware’s Chancery Court.
The true-up was “a pretext for what is in reality a windfall of over $40 million” obtained through self-dealing, the suit says. “And it is a pretext that has no logical end point: When the company issues more shares to raise money going forward, defendants apparently will feel entitled to be ‘trued up’ again.”
Northwest didn’t immediately respond to a request for comment Thursday.
The derivative suit, originally filed under seal March 18, accuses the drug company’s board of making “a mockery of the concept of director ‘disinterest’” by having different board factions grant each other the option awards, then claiming each group was neutral toward the other.
The process “lacked any semblance of sound corporate governance,” according to the complaint. The board also allegedly declined to put the true-up to a shareholder vote, as it previously had when paying itself, after “likely” realizing its rationale wouldn’t pass muster with investors.
“Of course, public stockholders” couldn’t “simply take more shares from the company in order to offset the dilution,” the suit says. “The true-up awards are blatantly unfair.”
Cause of Action: Breach of fiduciary duty; unjust enrichment.
Relief: Damages, rescission of the true-up, costs, and fees.
Attorneys: The investor is represented by Smith, Katzenstein & Jenkins LLP and Purcell Julie & Lefkowitz LLP.
The case is Schaeffer v. Black, Del. Ch., No. 2022-0259, complaint unsealed 3/23/22.
Flipper - In March 2020 I wrote to the company literally begging them to update clinicaltrial.gov for exactly that reason, the response I got for
`Dave` (the organ grinders monkey) was frankly insulting.
As regards our Scandinavian friend whilst he`s a genuine long he is also most definitely inebriated on his own exuberance.
As regards the quiet period and Iwasadivers conversation with the company, well you should call LG as he is now singing like a canary.
For my part I wrote to the MHRA under the Freedom of Information Act, and whilst they are allowed 15 days to respond they actually responded in 72 hours.
As regards data journal & MHRA well they have to come before the ASM .
The ASM must be held within 12 months of the previous ASM and I am reliably informed the 13th month rule is not for a company to pick and chose whether they use it and last years 13th month ASM was only acceptable due to Covids wider impact so we must hold the ASM latest around 18th May and send out invitations and resolutions about 6 weeks before.
As regards Duffy, Flipper he wasnt a plant from Merck ,he simply joined in good faith, realised Linda is impossible to work with and got out of Dodge as quickly as he could but I`m sure he did help with the SAP.
If and when you speak to LG, he`s got a new classic line its pure comedy gold..` I wont be rushed by anyone `.. my god the irony ..
Merck stops keytruda prostate cancer trial as results disappoint(Alliance News) - Merck & Co Inc said on Tuesday it will stop the phrase three trial investigating its anti-PD-1 therapy, keytruda, in combination with lynparza for the treatment of prostate cancer.
The New Jersey, US-based pharmaceutical company said it was discontinuing the study at the recommendation of an independent data monitoring committee whose analysis suggested that the combination of keytruda and lynparza did not meet its primary endpoints.
Analysis suggested that the combination did not improve overall survival when compared to the control arm of either abiraterone acetate or enzalutamide, both of which also are prostate cancer treatments. In addition, earlier analysis showed that radiographic progression free survival did show improvement when compared to the same control arm.
The trial was investigating Merck's keytruda in combination with cancer drug lynparza for the treatment of patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy and either abiraterone acetate or enzalutamide.
Further, Merck explained that the combination was also associated with a higher incidence of grade 3 to 5 adverse events and drug-related serious adverse events, compared to the control arm. A grade 5 adverse event is one resulting in death.
"Merck continues to evaluate the combination of keytruda and lynpraza in a range of cancers, and to research other keytruda-based combinations for patients with advanced prostate cancer," said Roy Baynes, vice senior president & head of global clinical development, chief medical officer at Merck Research Laboratories.
Merck shares were down 0.8% at USD77.20 in the New York pre-market on Tuesday.
By Heather Rydings; heatherrydings@alliancenews.com
Copyright 2022 Alliance News Limited. All Rights Reserved.
Alliance News
MHRA publishes guidance on new marketing authorisation assessment routes
link to site
Published on 11-Jan-2021
by Practical Law Life Sciences
The MHRA has published detailed guidance on new marketing authorisation assessment routes.
Speedread
The Medicines and Healthcare Products Regulatory Agency has published guidance on the following new marketing authorisation (MA) assessment routes available in the UK following the end of the Brexit transition period: 150-day national assessments, rolling reviews, the European Commission Decision reliance procedure, the decentralised and mutual recognition reliance procedure and the unfettered access procedure.
150-day national assessments
Guidance on 150-day assessment for national applications for medicines describes a new national accelerated assessment route for MAs. Under this route, the MHRA will evaluate a UK, Great Britain (GB) or Northern Ireland (NI) MA application and reach an opinion within 150 days of a valid application being submitted. The guidance states that the application route is available for "all high-quality new MA applications submitted to MHRA" and sets out specific advice for new active substances and biosmilar products and for existing active substances.
Timetable
The assessment runs in two phases totalling 150 days with a 60-day clock off period between phases if needed. The first assessment phase will be completed 80 days after the clock starts. Any issues arising during the first phase will be raised with applicants in a "letter requesting further information" (RFI letter). These issues should be addressed within the clock off period. The guidance states that requests to extend the clock off period for up to a further 60 days "may be granted only for exceptions". Phase I assessment will also address eligibility for grant of orphan status.
The second phase of the assessment will start once the applicants' responses are received. The MHRA will operate a 'fixed submission date' system to facilitate consultation with the Commission on Human Medicines (CHM). The guidance recommends that applicants contact the MHRA Assessment Team ahead of their intended date of response submission to align with the CHM's meeting schedule.
Application process
For new active substances and biosimilar products, the guidance describes:
Actions to take prior to submission. Applicants are advised to email the MHRA at AcceleratedandRollingReview@mhra.gov.uk stating the intended date of dossier submission and whether the MA application is to be submitted to UK, GB only or NI only.
The purpose of the pre-submission meeting and issues applicants may wish to raise at the meeting.
For existing active substances applications, the guidance refers applicants to the MHRA guidance on Reference Medicinal Products for applications made only to GB. Applicants are also advised to consult any MHRA product-specific bioequivalence guidance for applications made only to GB.
For both new active substances and biosimilars and existing active substances, the guidance describes the content and format of documents that make up a valid application or dossier. These include common technical (CTD) modules 2-5 and a UK specific CTD module 1, the summary of product characteristics and patient information leaflet and, if applicable, an active substance master file. Applications must also include a cover letter. The cover letter should detail the intention to seek orphan status or an MA under exceptional circumstances, as applicable. Applications should be submitted via the MHRA Submission Portal.
Appeals
Applicants can request a review of a decision not to grant an MA. The review procedure is set out in Schedule 5, and paragraph 11 of Schedule 11, to the Human Medicines Regulations 2012 (SI 2012/1916).
Rolling review
Rolling review for marketing authorisation applications describes a new route for MA applications which aims to streamline the development of novel medicines. MA applications for any new active substance, based on a "full dossier’" including biological products, are eligible for the route. Biosimilars are also eligible. Under this procedure, applicants submit increments of the electronic common technical document (eCTD) dossier to the MHRA for pre-assessment rather than as part of a consolidated full dossier submission. The modular approach aims to reduce risk of failure at the final phase of the assessment.
Timetable
Assessment of the first module will start from Day 0 with the assessment cycle being completed within 60 days. Following each assessment cycle, a Module Assessment Summary (MAS) will be issued by Day 60. The MAS enables the applicant to update the module, and the updated modules should be included in the final phase.
The final phase should be completed within 100 days in two stages with a clock off period after 60 days. The MHRA may issue an RFI by Day 60 and applicants will be able to discuss any issues identified in the RFI with the MHRA within 30 days. The clock then resumes on Day 61 with the final decision on approvability reached by Day 100. Orphan status will be determined at the time of grant of the MA.
Application process
Pre-assessment of modules
Applicants should request a pre-submission meeting where the product, its intended target populations and the data in each module to be submitted is discussed. Applicants may specify MA application designations for UK, GB only or NI only.
To apply for the pre-submission meeting, applicants should forward a copy of the completed application to AcceleratedandRollingReview@mhra.gov.uk. Applications, including the initial module(s) to be assessed, should be submitted via the MHRA Portal.
Under the modular approach, quality, non-clinical and clinical data may be submitted (in the common technical document format) separately or jointly, depending on individual circumstances and/or data availability.
Final phase
For the final phase applicants submit a complete application including updated versions of the modules evaluated previously. The guidance recommends a pre-submission meeting with the MHRA approximately 90 days before the intended submission for the final phase. At the meeting applicants can provide a short summary of the dossier and raise any special issues such as requests for consideration for an orphan or conditional MA or MA under exceptional circumstances.
A paediatric investigation plan compliance check should be completed 60 days before the intended submission. The guidance directs applicants to the MHRA's separate guidance on Procedures for UK Paediatric Investigation Plans (PIPs) for information on the compliance check.
The MHRA will operate a fixed submission date to enable consultation with the CHM and will publish a schedule of submission dates.
Appeals
Applicants can request a review of a decision not to grant an MA using the procedure set out in Schedule 5, and paragraph 11 of Schedule 11, to the Human Medicines Regulations 2012. If an applicant wishes to appeal the refusal of orphan status designation, the grant of a MA will only be possible when the appeal process is completed.
Fees
Each phase of assessment (for quality, non-clinical and clinical modules) will attract a fee as set out in Regulation 28(A) of Schedule 2 to the Medicines (Products for Human Use) (Fees) Regulations 2016 (SI 2016/190).
European Commission (EC) Decision reliance procedure
European Commission (EC) Decision Reliance Procedure describes a new MA procedure for GB through which the MHRA may rely on EC approvals under the EU centralised procedure. The EC Decision reliance procedure (ECDRP) will be available for a period of two years from 1 January 2021.
Timetable
The MHRA has stated its aim to determine GB MAs under the ECDRP as soon as possible and suggested that a delay in submission may affect the 67-day timeline. There is the possibility that the MHRA may make major objections or require significant amendment of the product information, which will move the application on to the standard national procedure timetable. But the MHRA has stated that this would be rare. The guidance also states that points of clarification (for example, relating to an incomplete dossier or missing assessment reports) may cause delays.
The timetable is different depending on when the application is made in relation to the EMA's Committee for Medicinal Products for Human Use (CHMP) opinion. If the submission is made within five days of the CHMP opinion, then a 67-day timetable applies from the date of the CHMP opinion (provided the EC decision has been received). If the application is made more than five days after the CHMP opinion, then the timetable starts on the date that the MHRA validates the application, and the MHRA has stated that determination may be delayed in this scenario.
The MHRA promises in the guidance to raise concerns about approvability at the earliest opportunity. It also states that issues identified during assessment will be communicated by Day 46 and the MHRA expects to be able to resolve those issues without affecting the overall 67-day timetable.
Application process
The guidance sets out what applicants must do to apply for a GB MA under the ECDRP. It also refers to a fee that applies to the application after receipt of the dossier.
An applicant must first have a GB MA (known as PLGB) number. The guidance recommends that, once a positive CHMP opinion is anticipated, applicants should submit a letter of intent including:
A statement that the applicant intends to submit an ECDRP application.
The intended timing of the application, which should be at least four weeks after the letter of intent.
Disclosure of all iterations of the CHMP assessment reports.
A statement confirming whether the applicant intends to apply for orphan designation.
The guidance explains that an application for GB MA can be made to the MHRA any time after EU approval, but the MHRA's intention is that applicants submit their application immediately on receipt of a positive CHMP opinion. The application should be submitted to the MHRA as a single eCTD (containing the entire dossier, including responses to CHMP questions) using MHRA Submissions. The dossier is not required if it has already been submitted to the MHRA as part of a NI application and no changes are required. The applicant should also submit all iterations of the CHMP assessment reports and opinion for the initial centralised procedure application and any variations, as well as the proposed product information.
To apply for GB orphan designation, applicants will need to include a specific GB form in the eCTD. Where EU or UK paediatric requirements apply, information and documents relating to those requirements must be included in the eCTD along with a specific overview table.
Finally, applications must include a cover letter containing various information listed in the guidance (including the centralised procedure number, a list of assessment reports and details of compliance with paediatric requirements) and several declarations concerning the conformance of the ECDRP application to the Commission approval, and the related CHMP assessment and opinion, on which it is based.
The applicant is also required to confirm:
The relevant Commission decision by providing the decision letter on the day of receipt.
Any applicable decision of the EMA's Committee on Orphan Medicinal Products.
Decentralised and mutual recognition reliance procedure
Decentralised and mutual recognition reliance procedure for marketing authorisations sets out a new MA procedure, known as the mutual recognition and decentralised reliance procedure (MRDCRP), for UK and GB through which the MHRA may rely on an approval of any member state of the EU or European Economic Area (EEA) under the EU decentralised and mutual recognition procedures.
Timetable
The MHRA has stated that the first-round assessment should be completed by Day 42, at which point an MA will be granted if no concerns are raised. The MHRA may raise an RFI which will stop the application timetable for up to 28 days. In the guidance, the MHRA has made the general promise that MAs will be granted within 67 days if there are no outstanding points at Day 65.
There is the possibility that the MHRA may make major objections, require substantial amendment of the product information, or raise concerns that remain outstanding at Day 65, which will move the application on to the standard national procedure timetable. The guidance also states that points for clarification (for example, relating to an incomplete dossier or missing assessment reports) may cause delays.
Application process
The guidance sets out what applicants must do to apply for a UK or GB MA under the MRDCRP. It also refers to a fee that applies to the application.
An applicant must first have a PL or PLGB number, as applicable. Then the applicant should submit the dossier as an eCTD using MHRA Submissions. The guidance emphasises that the submitted dossier should be the entire dossier approved under the mutual recognition or decentralised procedure in the EU, including responses to reference member state (RMS) and concerned member state (CMS) questions. The applicant should also submit all iterations of the RMS assessment reports and end of procedure documents for the initial EU application and any variations, as well as the RMS MA grant letter and the proposed product information.
To apply for GB orphan designation, applicants will need to include a specific GB form in the eCTD. Where EU or UK paediatric requirements apply, information and documents relating to those requirements must be included in the eCTD along with a specific overview table.
Finally, applications must include a cover letter containing various information listed in the guidance (including the relevant mutual recognition or decentralised procedure number, a list of any product information differences, a list of assessment reports and details of compliance with paediatric requirements) and several declarations concerning the conformance of the MRDCRP application to the EU or EEA member state approval on which it is based.
Unfettered access procedure for marketing authorisations approved in Northern Ireland
Unfettered Access Procedure for marketing authorisations approved in Northern Ireland describes a new MA application procedure, known as the unfettered access procedure (UAP) that allows GB approval of medicines with existing MA covering NI.
Timetable
In the guidance, the MHRA has stated its intention to determine applications for recognition within 67 days of the MHRA's validation of the application, although the MHRA considers that the vast majority of GB MAs should be approved by Day 42 (after the first round of assessment). In the guidance, the MHRA states its view that issues identified during assessment should be resolvable within the 67-day timetable. There is, however, a small possibility that the MHRA may make major objections or require significant amendment of the product information, which will move the application on to the normal national timeline. The guidance also states that points for clarification (for example, relating to an incomplete dossier or missing assessment reports) may cause delays.
Application process
The guidance sets out eligibility criteria and details of what applicants must do to apply for a GB MA under the UAP.
The guidance explains that the UAP will be available if:
The relevant MA holder is established in NI.
The relevant product meets the definition of Qualifying Northern Ireland Goods (QNIG), which is found in the Definition of Qualifying Northern Ireland Goods (EU Exit) Regulations 2020 (SI 2020/1454). Those regulations were made under section 8C(6) of the European Union (Withdrawal) Act 2018, which gave the UK government the power to define QNIG by regulations.
An applicant must first have a PLGB number. Then the applicant should submit the dossier as an eCTD using MHRA Submissions, although this is not required if the MHRA was sent the dossier with a NI application. The guidance emphasises that the submitted dossier should be the entire dossier approved under the relevant procedure, including responses to questions raised during those procedures. The applicant should also submit all iterations of the assessment reports and end of procedure documents for the initial UK or EU application and any variations, as well as the MA grant letter and the proposed product information.
To apply for GB orphan designation, applicants will need to include a specific GB form in the eCTD. Where EU or UK paediatric requirements apply, information and documents relating to those requirements must be included in the eCTD along with a specific overview table.
Finally, applications must include a cover letter containing various information listed in the guidance (including the NI procedure number, a list of assessment reports and details of compliance with paediatric requirements) and several declarations concerning the conformance of the UAP application to the NI approval on which it is based.
Source
MHRA: New guidance and information for industry from the MHRA.
END OF DOCUMENT
RESOURCE ID W-029-1301
© 2022 THOMSON REUTERS. ALL RIGHTS RESERVED.
Northwest Biotherapeutics Announces Commencement Of Cancer Vaccine Production At Its Sawston, UK Facility
Northwest Biotherapeutics Announces Commencement Of Cancer Vaccine Production At Its Sawston, UK Facility PR Newswire BETHESDA, Md., Feb. 17, 2022 BETHESDA, Md., Feb.
17, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid
tumor cancers, today announced commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production ...
Prof Ashkan BA(Hons), BSc(Hons), Dip Mus, MB BCh (Commend),MD, MRCP(UK),FRCS(Eng.),FRCP, FRCPS, FRCPath, FRCS (SN) said
"gives new hope to the patients with this terrible disease".
Adam Feuerstein BA (Pol Sci) Online journalist, ‘Tweeter’ and self proclaimed ‘Night King of Biotech ‘ said:
‘Grapefruit juice’
Sorry for your loss Gary.
All the best everyone I`m done here, many of you have my mobile so please feel free to continue to exchange ideas ( whatsapp / telegram etc ) .
Maybe I`ll pop back after data .
Bye ..
Thanks , I didnt see the program , but my friend had 1 legion in his brain a month ago then 14 two weeks ago ... shocking
... and you`ll make <$1m out of that in the short term....
Agreed, agreed, agreed..
Thanks - Bloomberg only update o/s from company filings so its always behind the curve
Flipper - remember you asked about how Large Pharm
would pay for a multibillion acquisition ..
Merck just announced this:
*MERCK & CO. KICKS OFF FIVE-PART BOND SALE FOR ACCELERON DEAL
Merck to Lead Five U.S. High-Grade Corporate Bond Sales Tuesday
By Michael Gambale
(Bloomberg) -- Five companies are looking to sell U.S. investment-grade corporate bonds on Tuesday, according to an informal survey of debt underwriters.
Merck kicked off marketing for a five-part bond deal. The transaction, which will help fund its acquisition of Acceleron, has a target size of $8 billion, according to a person familiar with the matter. GA Global Funding Trust also announced a bond sale Tuesday.
Western Digital wrapped up marketing outreach, making it a candidate to issue bonds while state-owned Mexican company Pemex hired banks for a potential 10-year senior unsecured notes sale.
The primary market is wide open for firms looking to sell debt with financial markets pointing to a strong open. Equity futures are surging higher, Treasury yields are mixed and the high-grade CDX is tighter by almost 1.5 basis points.
Weekly volume stands at $16 billion against estimates of about $25 billion. After Tuesday, volume should creep close to the $25 billion consensus and actual volume is likely to handily beat expectations later this week.
Eight deals priced on Monday while none were sold last Tuesday (at least 6 issuers stood down)
There are no overnight trades
Brian Smith’s New issue analysis: After guiding to a base case of $4 billion with room for growth, Swiss pharmaceutical company Roche priced a $6 billion deal evenly split across a new 7s, 10s and 30s to partially fund the ~$21 billion share repurchase from Novartis. The bonds looked to come with minimal to no new issue concession driven by an order book that peaked at $17 billion before closing at $15 billion
For more, see the daybook and the pipeline
Captain how many shares O/S now pse ?
Is that based on your female intuition or just a long history of overpromising by the company .. ?
Maybe but I feel there are just too many agencies involved to be that co-ordinated ..
Anyway I`m now journal incorporating TLD :
20% Before year end
35% Before mid Jan
65% Before mid Feb
95% Before mid March ..