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thankfully after they finally (after 3 years and a few months) submitted their first request for marketing approval it's out of their hands. Unless of course, the MHRA will pull an RFI. In that case, NWBO has a maximum of 2 months to answer the questions the MHRA may have... yikes a real DEADline and NWBO.
We can only beg the Gods of drug approval that the MHRA please have not any questions for NWBO for they will most certainly screw up the RFI Clockstop of max 2 months, and no the MHRA rarely gives an extension for this 2 months RFI period.
So according to you when dr Liau mistakenly says something (that she corrected later) we should take those words as the golden standard.
However, when Dr. Liau publishes her findings in a prestigious medical journal with strict editorial we should all dismiss what she is saying as utter bull nonsense.
You are the biggest clown ass on this board. I have heard they are looking for new clowns at Cirque du Soleil you should seriously apply!
The problem for the markets was that NWBO once again came back on their word with the "several weeks" it may still take, whereas previously they said two weeks after submitted to the publisher. The market did not like yet another NWBO delay.
The word salad didnt help either
Gary the point Hof is making is that with every new trial started a new trial design (which the SAP (Statistical Analytic Plan) is part of) has to be submitted to the RA which after the data has been collected will be analyzed. After the RA has accepted the trial design (as the MHRA and EMA did with DCVAXL) the approval for the drug after it has met its endpoints as agreed upon with the RA will become much more likely.
Ass Exwannebe claims that no trial design/SAP is needed when starting/conducting a medical trial just that the drug is safe which is absurd and ridiculous.
Exwannebe has zero knowledge of the way biotech trials are being conducted.
The MHRA bought into NWBO's most recent trial design when they submitted PIP and thus the MHRA will also accept the way NWBO submitted the data to the MHRA from the DCVAXL trial.
the problem is NWBO management does not have a clue how long it will take. They never had a clue how long their next step would take and made many misguidances in that regard. The difference now is that they are clumsy stumbling in trying to keep shareholders informed. Its a month its three weeks its this month november its several weeks. Clownesk
They are making complete and utter fools of themselves
required supporting documents have nothing to do with anything else than GBM n and or r.
It could however perhaps mean that they are in ongoing discussion with the MHRA
Thanks
ha yes you noticed Correct we hired a lot of new people
The most inept incapable deceiving management in biotech history ever.
I agree it looks like the progress is in reverse. Apparently, they are having some big problems with a certain part of the application.
If they will ever be able to fix it and how long that will take is the million dollar question.
I dont like snickers brrrr
this management is mind boggling inept
I already thanked you
yes you did say that I quoted you. But you didnt answer my question so if you be so kind to answer my question:
Did Dr. Ashkan say they would submit to the FDA (there)after the MHRA?
thank you
Did Dr. Ashkan say they would submit to the FDA right after MHRA?
I find it highly amusing that you an IT guy think you you know better than Dr Ashkan an esteemed UK brain surgeon. You are making a complete and utter clown of yourself. Do you really think Dr Ashkan would be still bothered with DCVAXL approval if he was not convinced the MHRA would approve and to that as Ashkan stated in a few months?
So lets see Ex the anonymous IT guy with no biotech or medical background whatsoever from the US or Dr Ashkan An esteemed UK brain surgeon.
Very difficult decision to make here lol
no its 80 days. If the MHRA has no questions after 80 days then there is no need to not pull a 60-day RFI (request for approval) clock stop. And if there is no need for a clock stop/RFI then there is also no need for the 70 days AFTER the clock stop to go over the answers provided by the biotech in the clock stop period. And if there is no need for a clock stop/ RFI then the MHRA decision can be made at the end of the 80 days.
So its 80 days after they submit if there are no questions from the MHRA (which coincides with Ashkan's "we will hear in a few months")
or its 7 months after they submit if there will be RFI and the clocks stop for 60 days
lol I have bene called a fudster here many times
I made a mistake if no RFI then its 80 days (only the first phase of the 80 + 60 (for the RFI) +70
80 days would coincide with Ashkan's" in the next few months we will hear back."
Its a 150-Day Accelerated Approval timeline 80 + 60 (for the RFI) +70 ( 7 months). So if NWBO submits on Dec 14th then Half - End July 2024 but with the Dec holidays, its safe to say Aug 1
If the MHRA does not pull an FRI (request for approval) then that timeline is 2 months shorter (5 months) so June 1 2024
So what is a few months?
dude relax my remark was not aimed at whatever meaningless fight you picket in the post I responded to.
I am saying You are starting to enjoy the pointing out of NWBO shortcomings just a tiny bit too much Mike, in general so over all your posts from the last 6 months.
Free advice: take the weekend NWBO off and take a nice long walk.
You are starting to enjoy the pointing out of NWBO shortcomings just a tiny bit too much Mike
at this point, I rather have a 15% gain in my hand than 100% fantasy birds in the bush
100% agree again. You are on fire lately Happy :)
Exactly 100% agree. The market does not trust nor puts any value in NWBO management forward-looking statements
Now I understand what is going on here. You grave for attention and know when you post something ridiculous and outrageous you get a lot of attention, negative attention, but still attention. Dude get some serious therapy for your graving of attention disorder!
Here for you in Georgia
https://www.novaclinic.life/practice-overview/atlanta-alpharetta-ga-natural-treatments-for-attention-deficit-disorder/
lol yes thats a bit too much of a punishment hahaha
at some point, the MAA will be submitted, at some point, it will be accepted at some point the MHRA will approve DCVAXL and most importantly after I sell after UK approval at some point I will be free from this f@cking NWBO BS. Freedom at last. Next year spring/summer somewhere
thats correct yes,
Then lets now debate for 5 weeks whether 4-5 weeks is a few weeks hahahahaha
85% of MHRA applications receive news of accepted or not two weeks after the applications has been submitted. So its not that far fetched.
Merck can be written off as a potential suitor for NWBO. They made their choice when they decided to invest up to $21 billion in Daiichis antibody-drug conjugates (ADCs). Of course it doesnt rule out any other Big Pharma
What I'm saying is that the explanation LSBR gave here to the text provided is NOT him/her making an excuse for management but explaining the text reasonably.
Sawston is now owned by anyone Sawston is the name of the business park Advent Bio Ltd operates in. Sawston Business Park Cambridge CB22 3JG UK
The CDMO Advent however is 100% owned by Linda Powers and Toucan and is for a large part financed by NWBO shareholders as a birthday present to Linda.