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The delay in preparing the MAA was because the consultants responsible for preparing the MAA application completely dropped the ball and messed up the initial application. From what I heard Bosch and Powers got together and produced a solid and correct application which caused the delay.
At least that's what I heard.
When I said that I did not expect an ASM without approval I was not aware of the information I have now.
Anyway You are completely wrong and ignoring MHRA regulation. that stipulates that MHRA Request for Information (RFI) may not always be necessary if the therapy has been used for ten years as a compassionate treatment for a specific cancer indication in the UK.
Im not saying that will happen to NWBO, Im saying that with each day passing without RFI that may very well be the case here.
You have so far not responded to my posts, which to me is saying a lot. I will repeat. You should ALSO acknowledge that there is a fair chance NWBO will never receive an RFI and inspections for the following reason:
In the case of a novel biologic undergoing a 150-day accelerated review for marketing authorization application (MAA) in the UK, inspections or a Request for Information (RFI) may not always be necessary if the therapy has been used for ten years as a compassionate treatment for a specific cancer indication in the country.
I was curious if anybody had managed to get a picture of the guy in red who kept popping up on the Webinar camera.
Market is tired of science experiments and academic presentations this late late in the game
Bigger on fire today
To they want to kill us: Don’t be only a lawyer be a UFC fighter. Hit them from all angles. Have you listen to some shorties that have gotten killed on a short or two? No, too busy listening to yourself. A lawsuit is ok but far from being innovative. $NWBO
— Michael Bigger (@biggercapital) July 2, 2024
You have been advocating and defending the build-up of Toucan subsidiaries Advent and Cognate for years. Now that we all can see that NWBO as a small biotech has held up and paused other medical trials among others promising Direct which would not have happened had they just stayed with CRL, its water under the bridge and all just theoretical.
Bigger on fire today. 100% agree
I want to hear from $NWBO how they’ll get to revenues after MHRA Approval (binary) in a presentation posted to the company’s website. Don’t waste my time yapping the lawsuit, I only care about the Judge’s decision.
— Michael Bigger (@biggercapital) July 2, 2024
They used some vague sht like SIGNS.....typical. 0% ORR is not SIGNS. Typical of this company. Bury a failed trial 10 years ago and then talk of reviving it with an endpoint that failed utterly.......
Some rumors argue against that idea
the only thing Im waiting for is UK approval. Hopefully, we will see the stock price get to $1 (but at this point Im not counting on anything) then Im OUT and can resume my mental health
So we have another example of extremely poor communication from management and the share price tanks as a result.
As usual, the 'longs' are on this board celebrating the price dropping. "Woohoo!! I can buy more!! Thanks for the gift!!! I hope it goes lower!!"
There is another faction of investors that are upset the price is dropping and their investment is losing value. And somehow, the latter group is labeled the "fudsters".
That's something.
There will be nothing with Direct no new trial no restart of old trials nothing as long as NWBO's finances are what they are now.
It was yet another empty sales pitch as was the combo joint trials promises 18 months ago.
senti thank you for your work and effort, but there is AI software that can do that in a few seconds. For example
https://restream.io/tools/transcribe-audio-to-text
I think the company have done very well given their very limited shoestring of a staff, but perhaps had they had a larger staff to handle the work load, things might have (would likely have) moved along more quickly.
Yes the burying of heads in the sand is mind boggling. People find it difficult to accept reality.
But you in turn should accept that there is a not-too-remote chance that there never will be RFi and Inspections as found by Flipper because NWBO has been around for years providing DCVAXL as compassionate use.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174682389
The need for inspections or RFIs during the MAA process depends on several factors, including the existing knowledge and data available for the therapy, its safety profile, and the level of scrutiny required by the regulatory authority. If the biologic has been used for a significant period and there is already substantial data and evidence supporting its safety and efficacy, the need for additional inspections or RFIs may be reduced.
You conveniently forget that after UK approval every GBM patient on the globe with money will flock to NWBO to get DCVAXL.
Every year globally, more than 300,000 cases of glioblastoma are diagnosed x 20% with the means to pay for the treatment = 60k ok 30k ok 10k ok 5k patients that will ring NWBO in 2025 x 200k = 1 billion revenue ok 500 million revenue ok 250 million ok $150 million in revenue ... in 2025
the point is NICE will not determine NWBO's revenue in 2025 the 300k patients worldwide will.
I apologize. After rereading the Managing MHRA Inspections (Clinical Trials of Investigational Medicinal Products) I realize that inspections are indeed during the whole approval procedure and not only part of the RFI.
Sorry
She told us they are trying to guess what the RFI will ask for so they are best prepared to respond quickly and efficiently. That means they haven’t gotten the RFI yet.
Inspections can only take place DURING the clock off RFI period. So they ARE IN the clock off period. Powers stated that they were ready to answer any question during the inspection. Answering questions is what happens IN and during the RFI
The problem is that the MHRA is overloaded and they are waiting for the inspections to take place which causes the delay of the RFI/Clock off period and that's where we are.
hopefully they will announce a deal the moment they are approved.
that is my biggest disappointment as well. With the they are open to it remark it looks as if they have been denied so far to make a deal.
I will say. If you study what the MHRA says about the request for information...
I now firmly believe that did receive the RFI, answered the questions and from that it derived that they are now waiting to be inspected. In case of NWBO it so happened that the RFI is taking longer than 60 days due to the busy schedule of the inspectors just as we saw with MIA.
Details. The applicant should prepare the responses to the MHRA questions as they have been introduced in the Request for Further Information ( RFI ) or the Commission on Human Medicines ( CHM ) Letter, by compiling them verbatim into this response template.
The goal of using an RFI is to gather information on a market in a formal, structured way. The document should identify the requirements an organization has while requesting specific answers to how the vendor will meet them.
MHRA Inspectors may visit a particular organisation to look at one trial (for example, a participating site as part of a broader inspection of a
multi-site trial’s co-ordinating organisation). They may also visit to do a ‘whole system’ inspection, when they will review an organisation’s facilities,
staff competency and training and assess its ability to conduct CTIMPs to appropriate standards. Most inspections will include a combination of staff
interviews, document reviews and facilities visits. An inspection of the organisation’s whole system may include any part of the organisation and any aspect of its operations having a bearing on CTIMP work. Example processes that may come under scrutiny include regulatory submissions, laboratories, investigational medicinal product (IMP) management, contract management, project management, trial-file management, quality assurance, training, computer systems, monitoring, pharmacovigilance, medical advisors, data management, statistical analysis, report writing, archives and the management of investigator teams
thank you,
I just hoped that she would announce they are in negotiations for joint trials or anything along those lines.
thanks. It its what it is. Xmas
from the looks of it the MHRA has not been in touch with NWBO since Les appearance on the big booze show.
He more or less said the same thing.
I would think for her to believe that inspections would have had to start and a RFI stop was already in process or has stopped since we reach the 60 day limit...
we believe MHRA is following the 150 day process but we do not have confirmation
damit no partners yes. They are open to it. But nothing yet
She has only explained the process but has not said anything about where in the process they are at.
yeah it sucks
Does not sound like 2024 decision is likely.
my thoughts exactly. Outragus
ooh ok :)
He absolutely, positively, 100% did not say this.
lol sometimes you are very funny hahaha
What "major" announcement could they make at the ASM that wouldn't have to be PRd beforehand?
also would ask what happened to all the additional direct trials that the company said they would run when having numerous stock sales and saying that was the purpose of those sales? Clearly it was just to keep the company going but numerous times they stated it was for direct.
They would have made that announcement before asking for the vote