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In a market with interest rate hikes non revenue-listed companies especially in biotech are all having difficulties. The SP downtrend in NWBO is not just especially aimed at NWBO its because NWBO is nonrevenue and OTC.
Tbh I don't think the submitting of the MAA will do much for the stock in this type of market environment. The approval of DCVAXL by the MHRA will especially if by that time NWBO has also submitted a request for approval with the FDA
Your claim there is a conflict of interest between Oncovir a company with a staff of 4! let me repeat 4 people, and Toucan is absurd. And your trust me on this one without providing any evidence such as a link, doesn't cut it.
Im a bit disappointed to be honest. A constructive critical attitude by activist shareholders toward any listed company will keep shareholders and management on their toes, especially with NWBO. However, if that activism turns into conspiracy theories then Linda's little media minions have won.
exactly. I have been saying for months here that NWBO put Eden in the backseat. If not they would have added new people to the project and replaced that guy but they didnt
Manual is what the state of the technique is now and that's what they will be approved and bought out for, end of story. Some posting here, are overthinking everything.
Lets just say that Les loves to talk when selling his NWBO securities, his timelines are always months off, as in the MAA in April case, but what he is stating has never been wrong including the JAMA months before it was published.
I dont have to prove anything if you dont believe that what my friend was told fine with me
Maybe competition already in trials will show better efficacy — 13% is not a high bar
Apples and oranges
Future P3 GBM trial data will have to compare to ALL GBM and ex-GBM types unmethylated, methylated, mesenchymal, etc to make a fair comparison against the DCVAXL trial data. So if future P3 data will want to prove they have found a more efficient treatment than DCVAXL and they only treated real GBM, as set determined by the WHO, they will have to compare it to DCVAXL methylated data which in that case NWBO's 13% efficacy OS is much higher
so the turning point will be MHRA approval. From what I gather from your post is that you think they will submit for approval with the FDA AFTER they have received approval in the UK. That's what Powers meant when she said strategic submitting the requests for approval.
Ooh and I completely forgot, remember LP said at the ASM they are planning to contract CRL again in the US. So that will also contribute to sufficient manufacturing for submitting BLA with FDA
I'm disagreeing with you here Gary. Of course, it is true that the FDA will demand sufficient manufacturing capacity to be able to grant approval. However when NWBO took out a loan on March 2 2023 to "be used for further buildout of the Sawston facility" they already knew that they would be granted MIA soon after as what happened 2 weeks later. Therefore the announcement about the further buildout of the Sawston facility was most definitely NOT to satisfy any (new) requirements set by the MHRA for MIA. The further buildout must therefore be to be able to meet FDA manufacturing DCVAXL requirements.
Now we, you and I, do not know if the ongoing build-out of the Sawston facility will be enough to meet FDA requirements or when it will be finished, but to state as you do that "it's clear that they can't do that" has no basis, you have not explained why you are so sure of that. I personally think they are very close to having enough manufacturing capacity to meet FDA requirements.
Then you state
If Eden must be ready to apply you don't apply
Its absurd to suggest NWBO is waiting for Eden to be ready. That could easily take another 3 to 5 years. First of all, FDA is not making unrealistic demands of NWBO/ or any biotech to work with future not yet available unproven state-of-the-art technology, and thus then to dismisses the present technology of manual manufacturing.
Second If you look at the number of people working at NWBO's subsidiary Flaskworks which is still only 5 and has not expanded over the last years if ever. One would expect that if Eden is front and center for the approval of DCVAXL NWBO would expand the number of people working at Flaskworks to shorten the process. But no such thing. It looks to me that NWBO has put Eden in the backseat, as in a nice R&D, but for a further future with a mizzly 5 staff working of which only 3 people doing hardcore development of Eden tech. https://www.linkedin.com/company/flaskworks/people/
Third. Why would the FDA make a, for now, impossible demand such as Eden for the manufacturing part of the approval, and the MHRA and EMA have no problem with manual production?
yes Anavex has a better balance sheet but has not shown any proof to have an effective drug. So you rather are invested in a biotech with a great balance sheet but not a working drug then vice versa? Got it
$NWBO is in the business of press release production to support their need to sell unregistered securities and other classes of preferred shares to support the piss poor capital structure and negative common shareholder equity.
Do you mean a pump piece as in published in Nov 2022 where 70+ brain surgeons on top of their field signed off on an article in the most prestige Medical journal out there the Jama stating DCVAXL (NWBOs leading drug) is highly efficient? Do you mean to say that's a pump piece? Which by the way is now in the top 5 best-read articles in the Jama ever https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
An article in Jama stating the drug works better than anything out there signed off by 70+ MDs on top of their field is something tbh I do not see Anavex achieve with its cheated, twisted fumbled upon data from its P2/3 AD trial.
listen Im telling you. They will get approval for L they will get bought. Just at snail-turtle speed. But not for the hundreds of billions of people think this will be bought for. They will be bought for around $20 -24 so $ 13-15 a share.
I agree with you that management should give more guidance on where they are in the process and what their next step is, which in turn would support the SP. But to say nothing has been disclosed is nonsense. They have disclosed TLD, there is a JA from which both can be concluded that DVAXL is highly efficient. From all the other info including the MIA certificate can be concluded that its highly likely that DCVAXL will be approved. Also, management did say they will submit MAA this year.
This is a complete overreaction. Some large investors are dumping thats for sure and very few are willing to step in. Now Im starting to think that even if today it was announced MAA is submitted still it would do little to the SP.
Mr market is not kind for nonrevenue cash-strapped OTC biotech
aah ok I see. Good for you, I hope I will be in the same position between now and 2 years. Im running two businesses in the internet (marketing) field. Hopefully, together with my NWBO investment and selling these businesses I can retire between now and 2 years
I am convinced they will file a request for approval with the MHRA in June max July (which was planned for May) and will be awarded approval in Fall (probably Oct). Also, I do believe they will file a request for approval with the FDA this year.
Terrible to buy at that price or terrible that it would get so low?
Both. I have been buying a lot at around 60 and never thought this absolute crash from 1.25 after JAMA to where we are now and still not done cratering :(. I will have little choice but to average more down which I do not want to do really :(
As soon as MAA is submitted I see the trend turning up again.
Life is what happens, life goes on while NWBO takes decades. People have bills to pay, kids, going to college, mortgages due, that holiday home in Aspen, and inflation. So they sell to get frozen cash freed up with too little interest to buy big in. No large investment funds. Also, a lot of trading platforms deny access to the OTC market
yes for FDA approval sufficient manufacturing capacity is necessary and thus, therefore, sufficient production capacity is a prerequisite for (a request) for approval.
educate yourself. If you lack knowledge in biotech, then I suggest you should invest in other more simple securities. Mr. Grammerschool
Still, given that many pro-management arguments included “Manufacturing, Manufacturing, Manufacturing” and given that we appear to be overdue for an application to be submitted to MHRA, it is plausible we are waiting on a build out.
Thanks Exactly. One period it is NWBO needs to build out, build out therefore we are waiting. The other its a short narrative. They cant make up their mind
The proceeds will be used for further buildout of the Sawston facility, and ongoing expanded activities related to preparation of an application for product approval
again:
further buildout of the Sawston facility, and ongoing expanded activities related to preparation of an application for product approval
NWBO is clearly saying they see the buildout of Sawston as PART OF the preparation of the application for product approval. LP also said she wants to initiate strategic submission for the request of approval. If that means including the FDA then the facility she is of such a state that the FDA will want to see the capacity at Sawston as sufficient.
After Sawston is built out (June) sufficient for FDA /global capacity production they will submit.
For anyone wondering why we are still waiting for NWBO to submit the MAA. NWBO told us why. It's not the scanning of half a million pages more or less. It has nothing todo with the paperwork involved of getting the MAA ready.
On March 2, 2023 NWBO said this about a loan they took out:
The proceeds will be used for further buildout of the Sawston facility, [color=red]and ongoing expanded activitiesrelated to preparation of an application for product approval, in addition to regular company operations.
NWBO is waiting for the buildout of the Swaston facility before they submit the request for product approval as they said so on March 2, 2023
Through '17 hey lied about the trial concluding immenently based upon the number of predefined PFS then OS events being reached.
While in reality they were waiting on whatever than ended up taking years more.
No, they did not lie about a major shift in the direction the business should be heading in 2017 as was the subject. The stage they went through is PFS is a pseudoprogression. Amending SAP. Discussions with the FDA about amended SAP. Then disclosing to the public after they found out that indeed the amended SAP did not encounter any objections from the FDA.
dennis if I can ask what’s your level of confidence that we’re not waiting on Eden? I would not expect that but everything I think has been wrong pretty much. TIA
Hi pqr,
well of course when it comes to NWBO there are no guarantees of anything. First of all, there is no such thing as regulators directing NWBO prior to the approval process to reduce the production cost of DCVAXL in order to gain approval. Approval is solely based on medical efficiency. After the approval process, each country where DCVAXL has been approved will negotiate a price for DCVAXL with NWBO or Advent. Second from what we know the price for DCVAXL treatment is not that steep at all. So the assertion that was made that NWBO had no choice but to include Eden in the MAA approval process otherwise, by manual production, DCVAXL would be too expensive is absolute BS.
Second If NWBO wanted to include Eden in the DCVAXL production process for the MAA then it takes an unnecessary risk of delaying the approval with not months but many Q's if not years. Also if you look at the number of people working at NWBO's subsidiary Flaskworks which is still only 5 and has not expanded over the last years if ever. One would expect that in Eeden is front and center for the approval of DCVAXL, NWBO would expand the number of people working at Flaskworks to shorten the process.
But no such thing. It looks to me that NWBO has put Eden in the backseat as in nice R&D but for a far future with a mizzly 5 staff working of which only 3 staff doing hardcore development of Eeden tech.
I have heard Ashkan say he expects NICE reimbursement not far after approval. If approval is granted then the rule is insurance must reimburse the cost. Of course there are negotiations but only with the most outrageous prices, which the different committees responsible seem to have a problem with. DCAVXL really isnt one of those outrageous biotech prices, so yes please provide the link to Ashkan saying that.
To your second point. I was referring so much to lying over a timeline, which yes they have lied about before, but NWBO lying over a completely different process a completely different approach strategy and direction with the risk of years of delay. Thats no small thing to lie about.
I am not buying that at all. That really is panic for no reason. I know who Thermo is and I know he is not just making things up. They really are NOT waiting for Eden thank God.
So that puts us in 2024 before an MAA/BLA/Whatever-A can even be submitted
Ooh come on. That would mean not only did LP lie at the ASM when she outlined the timeline "right after MIA" but also in an official SEC doc where they said "plans for 2023" "the company plans to submit an application asap" . Then they also lied to investors such as Thermo and to SOS who as you claimed is a mouthpiece for the company, when they told them they will file first in April and then May now probably June.
all lies? Thats too much lying even for NWBO management.
I think Dr. Ashkan is plain wrong when or if he said DCVAXL manual production price is too steep. Do you have a quote of him saying that?
Yes, I agree with you that NWBO stated that they will submit MAA in 2023, but that does not mean that Powers did not give/outline a timeline for WHEN in 2023 they expect to submit, as Flipper described. She did.
It also does not mean that shareholders, given the fact that many things take longer when it comes to NWBO, should be surprised that the described/sketched/outlined expected date of submitting the MAA as provided by Powers is delayed. I was not surprised at all its now apparently expected in June.
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