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On October 15, 2024 ISS - EVA upgraded Northwest Biotherapeutics (NWBO.NaE) from UNDERWEIGHT to OVERWEIGHT.
sorry if repost but one of my minions sent it to me since i did not see it anywhere!
Latest MRHA newsletter -at least they are approving other cancer drugs!!!
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Clinical trials and investigations performance
The latest MHRA performance data show that clinical trials and investigations applications continue to be handled within statutory timescales. Since September 2023, all clinical trial applications have been assessed within the 30 days, with no backlogs.
Regulatory assessments for clinical trials have been completed in an average of 28 days for initial assessments (within the statutory timescale of 30 days) and an average of 27 days for assessments of amendments (within the statutory timescale of 35 days).
We have now embedded improvements in processing clinical trial applications into standard working practice. We will continue to make enhancements to make it easier and faster for applicants to gain approvals and to ensure the UK remains a prime destination for clinical trials.
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Consultation on statutory fees closing on 24 October
We would like to remind you that our consultation on statutory fees is still running and will close later in the month on 24 October. Please do make sure you submit your comments before the deadline. We would also like to encourage any micro or small-medium business to share their views, so that the consultation is as representative as possible. Find out more about the consultation and share your views
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Implementing the new UK clinical trials regulations
Together with our partners, the Health Research Authority (HRA), we are hosting a short webinar on Tuesday 15 October 2024, from 2pm – 4pm to introduce our joint plans to share draft guidance with stakeholders and to set out the anticipated timelines for implementing the new UK Clinical Trials regulations. Book your place now for Implementing the new UK Clinical Trials regulations Tickets, Tue, Oct 15, 2024 at 2:00 PM.
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MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox
We are calling for applications for manufacturers and developers of Artificial Intelligence (AI) medical devices, to join the AI Airlock regulatory sandbox.
The AI Airlock is a world leading regulatory sandbox for AI as a Medical Device (AIaMD). This pilot project will help us identify and address the challenges for regulating AI medical devices so that in the future, innovative and safe AI medical devices can be brought safely into use in the shortest time possible, for the benefit of patients and the NHS.
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Fruquintinib approved to treat adult patients with metastatic colorectal cancer ??
has We approved the new medicine fruquintinib (Fruzaqla) to treat adult patients with metastatic colorectal cancer (CRC). It is used when other treatments have not worked.
CRC is an abnormal growth of cells that begins in a part of the large intestine called the colon. When the cancer is metastatic, this means that it has spread to other parts of the body.
In patients with metastatic CRC, fruquintinib stops tumours from making new blood vessels and therefore slows down the growth of cancer. Blood vessels would usually provide the tumour with nutrients and oxygen.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
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We’re assured that the appropriate regulatory standards for the approval of this medicine have been met.? As with all products, we will keep its safety under close review."
The application for approval was supported by evidence obtained via two main studies (FRESCO-2 and FRESCO). FRESCO-2 involved 691 adults with previously treated metastatic colorectal cancer. The study included patients who had disease progression on, or were intolerant to, chemotherapy, biologics, and trifluridine/tipiracil (TAS-102) and/or regorafenib.
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New guidance to enhance the EAMS
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i'm still hanging on with my 200,000 shares at .01 but i do not expect much from $CLNV for months. so what if they get their funding. wall street wants revenue, profits and cashflow NOW!. CLNV supposedly have two sites up and running - Morrocco and india and those should be what the company should be expanding and getting more revenue at their 80% margins instead of begging for funding that never comes. CLNV makes it seems like WVA site is going to be the premier site - why are the Morrocco and India sites enough to get future customers interested in investing. with no additional revenues coming in for months this stock is a boat without oars. i pretty confident i will get a double eventually (.02) so that is why i'm hanging around - a double in a year is a great return. GLTA!
Dates Shares Outstanding Increase
10/31/2023 603,603,984
11/6/2023 604,103,984 500,000
1/23/2024 682,463,425 78,359,441
3/20/2024 692,519,265 10,055,840
4/1/2024 692,519,265 0
4/15/2024 693,701,083 1,181,818
9/25/2024 757,833,009 64,131,926
overall increase 154,229,025
i still own 200,000 shares at .011 so will just let those stay on the shelf.
i dumped my 2 mil shares this morning and moving on! this is dead money for awhile and might jump back in in a year! good luck to all you that stick with it! i like my chances with a cancer company that is about to get approvals from the UK N.WBO! sells for .33 with potential of $20
conditions on getting the $15mil-The Amended Letter sets forth certain terms and conditions that must be satisfied in order for the funds provided for in the WV Loan Guarantee to be made available to the Company, including, but not limited to, the delivery of certain equipment to the Project and certification by an independent third-party architect or engineer certifying that all such equipment is operational. OUCH!
Frank- have you disappeared? i know you said you don't like IHUB but it would be appreciated if you could dispel the dissolve rumors too! the stock price is acting like this company is headed for the toilet - almost a new 52 week low!
you remind me of a broken clock that is right two times a day! it has better record than you! but keep on guessing you will be right one of these days! LOL
the mgmt sure does not have a very good track record on when they think they will get funding. started pumping the funding last december and almost coming up to a year! pretty bad! wall street want revenues and without the funding no revenues in sight! i'm still holding but not for long better opportunities out there with better management.
i hope we get a pop when the news hits but i'm thinking that CLNV needs to show revenues from their installed machines and that ain't happening for awhile. nothing beats a recurring revenue stream with margins as high as CLNV has shown.
really-seems like they sure having a hard time bringing home the bacon. i have over 2 mil shares and i'm starting to lose interest in this company!
Aug 14th is court date! maybe some good news! i bought back in at .04
9 more days until 10q is due and once again volume is up. wonder if we get news before the 15th??? go $HNRC!
if i were to take a guess- insiders know a good 10Q is coming so they loaded up-that is why no news yet good volume. but as one of my favs says "i know nutting"
Latest MHRA News-at least they think they are doing a heck of a job!!!
Welcome
Welcome to the latest edition of MHRA News, our monthly newsletter for industry. We are committed to keeping you updated on what is going on at the MHRA and this newsletter is part of a broad effort to ensure transparency and communication.? We continue work to promote MHRA News across the sector to drive engagement and registration.
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Clinical trials and investigations performance
Our latest MHRA performance data as of 15th July shows that clinical trials applications continue to be handled within target statutory timescales.
Regulatory assessments for clinical trials have been completed in an average of 27 days for initial assessments (within the statutory timescale of 30 days) and an average of 27 days for assessments of amendments (within the statutory timescale of 35 days).
We have now embedded improvements in processing clinical trial applications into standard working practice. We will continue to make enhancements with new legislative measures to make it easier and faster for applicants to gain approvals and to ensure the UK remains a prime destination for clinical trials.
Our Notification Scheme, launched in October 2023, reduces the time to process applications by more than 50 percent, for those that meet the eligibility criteria. Register your interest.
More information about individual trial application status, is available by emailing clintrialhelpline@mhra.gov.uk
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Established medicines
Progress continues to be made in the clearance of marketing authorization applications for established medicines that are outside of statutory timescales.
International Recognition Procedure applications continue to be on track with 100% approvals in statutory timescales.
Since May 2024, we have made changes to the range of data we publish:
• We no longer report on reliance data, instead providing data about our performance in the International Recognition Procedure including innovative medicines (NAS – new active substances).
• We now publish data on the most requested information relating to timescales for validation, including validation of marketing authorization and variation applications, patient information quality unit (PIQU) and compliance reviews. All these procedures are complying with expected timescales.
• We have been working to adjust our approach for assessments of marketing authorisation applications, to maximise the effectiveness and efficiency of the process changes implemented on 1 March and continue to review this process alongside ongoing work with stakeholders. We encourage those who wish to provide feedback on these process changes to contact us directly at info@mhra.gov.uk.
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Updates to International Recognition Procedure guidance
Last month we updated our submission guidance for the International Recognition Procedure and eCTD on gov.uk, and we now provide a checklist for applicants to use to manage the quality of their applications. This ensures that applications are not unnecessarily delayed while we seek additional information from them. This update follows commitments made at the IRP webinar in April 24, the recording of which is now available.
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Annual Report and Accounts 2023-24
We've published our Annual Report and Accounts 2023-2024, which provides an overview of our performance and the events that have had most impact on the Agency during the past year. Some key highlights from the report include:
• Continuing our robust and effective regulation, taking appropriate action on identified safety issues
• Building on strong international relationships and domestic partnerships to enable rapid access to safe new medicines and healthcare products
• Making substantial progress towards restoring our performance, including major improvements in performance monitoring, enabling clear oversight and rapid action where issues start to develop
• Remaining committed to independence, objectivity, and evidence-based decision-making to uphold and protect patient safety and public health as our highest priority
Read the full report here.
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Product approval announcements
We have continued work to publish announcements to coincide with the conclusion of regulatory assessments, delivering on a key objective as listed within our corporate plan to build public trust and understanding of our work.?
Products we have recently communicated about include a treatment for serious heart problems in overweight or obese adults and the first generic raltegravir medicines to treat adult and paediatric patients infected by HIV.
Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.?The MHRA will keep the safety and effectiveness of these medicines under close review, as with all medicines.
To learn more about these latest approvals and keep up to date on our the vital work carried out by our approvals team visit our homepage.
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hopefully on the call Dan can clearly tell everyone how much of the 15 million will be received by CLNV and when since per the PR it doesn't seem like they have any of it yet. but the glass is still half full since it looks like CLNV will get it eventually!
the 2nd qtr 10q is due by 8/15 just like the 1st 10q was released on may 15th. here wer highlights from 1st qtr which IF TRUE why is HNRC selling for under .02 unless the rumors of CEO being a shdy character. i own at .02 so keep the pump going!!
Financial Results: Q1 2024 Ending March 31, 2024, vs Q1 2023 Ending March 31, 2023
Total revenue for three months was $4,292,940 vs $4,178,580, an increase of 2.7%.
Total earnings for three months were $2,736,961 vs $2,660,713, an increase of 2.8%.
Total assets for the period were $85,858,800 vs $92,839,255, a decrease of 7.5%.
The company recorded a net asset value (NAV) of $0.27 per share Q1 2024
if i could counterfeit $100 bills and get it away with it i sure would! so no wonder the naked shortseller sell the heck out of stocks since the SEC is worthless enforcing the crappy rules.
so thursday volume 1,113,446
and friday volume 994,318
tuesday/wed not even 100k so again the insiders know something! hopefully good
10Q is due by 8/15 so maybe something to look forward to! GO $HNRC
oh well bought another 25000 keep that volume churning
a new 52 week high would be a nice surprise! all pennies like to run!! come on $HRNC start jogging!!
obviously, you have been around for awhile so you see increase volume as more a pump than insiders loading up because they know something? TIA
nice volume so far-maybe news coming!!! $HNRC
Nice volume today and close above .02! excellent! go $CLNV- everyday we get closer to seeing that funding-pretty sure it will happen -just a waiting game - good place to add around .02!
Be nice if we get some good news by the next 10q due by 8/15! go $CLNV
with the 2nd qtr report coming up in 45 days - is CLNV getting revenue from Morrocco and India?? TIA
sounds like EBET becomes a shell company and hopefully the only thing going for it is the lawsuit (which i hope is on contingency so no cash outlays by a company with no assets). i sold the 100k shares i own at a nice loss so only have 1000. if anyone hears anything different please share. TIA
frank, Ohio? don't think i heard what is in the works for OHIO. care to share??
Close at .02 - clock starts again! soon the .02 will be left behind - i hope! Go $CLNV
i haven't been tracking it that close but here is what i previous had- guess i will start tracking closer in future!
CLNV O/S
10/31/2023 603,603,984
11/6/2023 604,103,984
7/2/2024 710,656,183
if we close under .02 that will be 3rd straight day- don't want those bastards to get the conversion at the lower share price!
that was last straw for me! i sold this morning - good luck to all that stick with this in hopes for settlement! moving on to the next lottery ticket! NWBO
back to counting- 2days close under .02! bring on the funding and get us over that magical nickel!!! $CLNV
nice to see over .10 today! maybe not all is lost for it to still be alive and kicking!
alright close above .02 start that clock again! real nice volume today over 5 million! maybe something is starting to free up that funding! go $CLNV!
Per my count its been 2 days in a row under .02! could use some news in next 3days to keep the snakes from getting their lower conversion price why would you agree unless you knew it wasn't going to happen!
Conversion price will be lowered to .0145 if share price closes below .02 for 5 consecutive days. don't need the extra dilution!
nice volume again this morning! picked up 60,000 at .0195! since wva already gave CLNV 1.75 mil i'm pretty confident the 15 mil loan will come one of these days! Go $CLNV!
you might be right otherwise we would be selling for .0001! and its actually going up this morning.
way to keep the glass half full! my concern is that if somehow Arista is involved with the lender - great way to get rid of lawsuit and that is why there hasn't been that much volume after every positive court decision. still don't understand why EBET would agree to the june 17th date moving forward. blows my mind what is going on!