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They've hired the very highly skilled people you referred to, now, to do that work. They understand the regulatory part, which is what lawyers do very well and these lawyers are extremely well qualified
I never said Advent is a bunch of lawyers, you are saying that. Advent is a fully-owned subsidiary of Toucan, employing very highly skilled people. Perhaps you want to comment on the educational level of Coopers & Lybrand Consulting as well? I am not invested in either.
NWBO however you know that listed company is run by two biotech incompetent lawyers.
Btw FYI Advent will never market DCVAXL nor has it developed DCVAXL
me:
If you are trying to develop and market a treatment for GBM with lawyers then its super tough yes.
Yup 75% to finance Advent a fully owned subsidiary of Toucan and 25% to fund the fumbling around of NWBO employees. Except for DI managing angry shareholders, Les selling BS and C prefs to finance Advent, and LP managing Advent and consultants, I have no F clue what the rest do all day.
And ooh of course before the donuts gets upset. A part of the C prefs proceeds is also used to pay the consultants to work on preparations for seeking approval (from the 10Q).
It is a lot tougher than she thought.
Its over obvious NWBOs priority is with Advent. As long as Advent and perhaps Flaskworks are not certified they will not move a finger other than to wait for the submitted JA. Thats it that's where are at.
No official TLD or ASM until the JA has been published. Which could take anywhere from today until 6 months.
And no submitting of MAA for DCVAXL with the MHRA until Advent and most likely Flaskworks has been certified which may take another 3-6 months
So we are looking at mid to end of 2023 until DCVAX L has been approved in the UK.
Things do take a while, but that is part of this kind of a process
Other than reality and the 10Q telling us, nope nothing
It has become overly apparent that NWBO management's priority is with Advent and thus Toucan. NWBO is just a convenient financing vehicle. Until Advent gets fully operational nothing gets done at NWBO for its shareholders.
well said 100% agree
I doubt any lawsuit NWBO might file will name Adam as a defendant.
Flipper44,
Unlikely he didn't know. The change is in the 2020 and 2021 Form 10-K.
The idea that they are waiting on Flaskworks is a bit far-fetched.
People just do not understand that even if Flaskworks is approved as a GMP manufacturing device, it is still a different process and cannot be used to manufacture the commercial DCVax-L w/o a lot more work.
I believe that it's the course that the company has chosen whether it required by the regulators or not. It would take a massive number of clean rooms to satisfy the regulators that they can handle the initial demand, I don't think that they or their contractors would want to make that investment to operate for a limited time until Flaskworks is approved.
Before I saw your post I was about to write one on why going to the regulators is taking so long but it is all here. I don't care how quickly you can do all the paperwork, until you have an approvable production facility you can't do a thing.
Here’s the fly in the ointment. Management has ostensibly restricted the information it provides to shareholders
lol didn’t know otiose is a potato potatoe tomato tomatoe thing
The part attributed to LL is that NWBO does not have patient level data. It is a fact that they do not.
the simple answer is Liau never said this:
"Liau has indicated that they do not have patient level data for the ECA and Medicenna's ACTUAL MEETING AND APPROVAL WITH THE FDA for their P3 with the hybrid ECA concluded that patient level data was needed for the hybrid ECA including those from external sources. Medicenna created a database with this patient level data for the ECA so they are convered"
She did say that when the FDA has not responded after 3 months after the SAP has been submitted that one can assume the FDA is on board with the SAP.
no my negativity regarding management has derived from management keep screwing everything up including and especially for patients. The rest of your " " is also complete and utter nonsense.
best wishes.
anyone warning that investing in biotech (such as in NWBO and Anavex) isnt straightforward and talking in certainties and absolutes (as you are doing) is a bad investment advice, is A-okay in my book and 100% correct.
Yeah biotech investing is dead easy, can’t go wrong!!!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170261953
nope ex makes a very good point and raises a fair question. On this one your Nonsensical statements is a Nonsensical statement
here is another one. If they have not submitted a request for approval in the UK, and by what ot looks like it that is indeed the case, then Dr. Pazdur’s ultimatum does not sail in the UK and there must be another reason. And that same reason (why they have not submitted approval in the UK) is ofcourse also the reason why they have not filed with the FDA.
let me help you flipper is telling you that there can not be any form of approval SOC or not if the production is not ramped up.
I really hope so, for the sake of the people that need treatment. Making them wait this long is just unacceptable and shameful as a result of the process
ooh those yes, the same deep, dirty underground players that put chips in Covid vaccines so they can control us. Bleep bleep, take me to your leader.
If someone says I know someone who knows someone who controls the biotech industry blabla then Im fading out.
deep ties in the biotech space
lol well as it stands now it already is. Btw totally unrelated foiled hats are already preventing many conspiracy diseases!
well if DCVAXL were to become SOC, then I do believe the helmet will be sidelined by insurance companies. Of course, if a patient after DCVAXL has not provided the necessary relief and still wants to turn to other alternatives the helmet could be that alternative's last straw but I am pretty insurance would not want to cover that.
I hope ofcourse hope they will be granted expedited approval, but I have been in biotech too long to know things are not always straightforward. It remains a P2b/3 trial and not a solid P3 trial thus I keep that caveat for the reasons provided.
I dont have a crystal bowl you dont have one either. :)
lol exactly. what could go wrong :)
So is a big hike in interest rate a material event for a large bank? Im pretty sure it will impact the SP of the bank. Or a cut in oil production of 10% by OPEC? Im also sure that will impact the SP of ExxonMobil.
Its business related which yes like I said may or may not move the SP.
https://www.investopedia.com/terms/m/materialnews.asp
Material news is news that a company releases that might affect the value of its securities or influence investors' decisions. It is any type of news that directly relates to the company's business, and depending on the news, it will move the company's share price up or down.
I agree. The haircut remark I made was a bit strong. A dent and then a bounce back. And the description confirmatory study is better suited. Thanks
I agree with you. I agree that the market expects a P3 if not the market would reflect a x3 higher MC for Anavex. So yes if the EXCELLENCE readout and especially the peer-reviewed medical journal indicates that a Phase 3 trial is likely not needed then that will have a huge impact on Anavexs SP/MC.
In my view, this is not a certain victory even if the data will show efficiency. And this is my opinion but I think/speculate that after the Aducanumab debacle AND because we also have Cassava claiming to have a working AD drug as well it would not surprise me if the FDA would want to be extra super careful not to make any new mistake and NOT give Ananvex or Cassava the benefit of the doubt which would result in Anavex having to start a final confirmatory P3 study
I agree with you. However, if the data is outstanding this will not happen. If the data shows mild efficiency and the market is left with some doubt the SP will collapse after a short pop.
very well-defined Steady.
Its actually a little bit different. A Material event means an event that will affect and impact the financial going concern of a listed company negatively, not the stock price. The SP is a reflection of how well the company is doing (at least if it's not a meme stock).
The suspense with the AD topline data is IF it's ambiguous and Anavex needs to start a final Phase 3 trial OR will it get approval based on the present 2/3 AD trial data?
Thats it. If Anavex needs to start a Phase 3 trial well the SP will get a haircut.
Conversely her own investments into cognate and advent which utilized NWBO’s capital to start and grow did fantastic. So while shareholders got decimated, LP did quite well. Nothing to see here tho carry on
DD your short narrative is getting old
First What you are saying is the stock price of biotechs in essence will always decrease? If that were the case then why on earth would anyone invest in an (early) stage biotech? There is absolutely no reason to invest in an biotech starting in its early development stage when its already settled the SP will decrease now is there. But NWBO is NOT in its early development stage now are they? Still, they are down 90% from the time LP took office.
Yes non revenue biotechs sell shares to finance its business. However, a well-run biotech, such as for example Anavex, trades shares for progress. So simply said biotech makes REAL ACTUAL progress SP rises, biotech dilutes SP decreases a small bit but stays above the SP it was before the reported progress, Biotech reports REAL ACTUAL progress SP rises etc. That's how well-run biotech works. Not NWBO. NWBO has not reported any progress but keeps diluting to keep financing a nonaffiliated other business thus SP tanks.
Advocating the never-ending decrease of NWBO SP as a good and natural phenomenon is absurd
since Linda Powers started as CEO the StockPice declined 90%.
Just let that sink in. mind-boggling.
All CEOs of all listed companies in every developed country especially the US are being settled on their performance by looking at the stock price performance, without exception. Ooh wait one exception according to the groupies not LP with a whopping -90%. Many CEOs of listed companies had to go over way less bad performance than that.
But of course its not Linda's fold, its the shorts, bears, wolf pack, AF, Novocure, the RA's etc fault. And of course its also the fault of longs like myself, PM, Grip etc pointing her performance out. Hey its even Flipper's fault when he says "continents are moving faster than NWBO". But not Lindas