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You see the leaving of a potential suiter for NWBO as an optimistic event? wow. If this is really true and Merck is no longer interested then that's very bad news Senti and not good.
well it is a sign on the wall. Why would Merck start a joint venture with Moderna to develop a personalized cancer vaccine (doesn't need to be for GBM but still) if they planned to acquire NWBO?
Betting on two horses? I think not. NWBO has kicked the can for so long that the can is broken now. And as far as we know NWBO still has not submitted a request for approval with any RA.
I wish you good healing for you Gary, hope and pray you will recover completely :)
as soon as the stock hits $2 at high volume Im out as well. And it will hit 2$ again there is always those who have not first hand had the pleasure to experience the stupidness of NWBO management
Correction I mean Project Orbis NOT The 21st Century Cures Act.
The 21st Century Cures Act RWE is realistic
Its a copy-paste error
I never claimed its impossible for a cancer treatment drug to be granted approval after a phase 2 drug, its only very rare. In the case of Gleevec there was no alternative and the FDA approved the drug with record speed for oral therapy for the treatment of patients with chronic myeloid leukemia (CML).
Like I said Im certain DCVAX will NOT be granted approval for other solid tumor cancer indications in other organs for most all of these indications already have treatments approved after phase 3 trials. The companies behind these drugs, after having invested hundreds of millions in phase 3, will have a field day suing the FDA over granting DCVAX approval after P2 and competing with their investment without a Phase 3 trial and thus without proving DCVAX is a better or equal treatment,
Take for example Gilead acquiring Immunomedics for solid tumors for 21 billion. Do you think Gilead is just going to accept a swift and small Phase 2 DCVAX trial for solid tumor breast cancer to compete with their 21 billion investment? Of course not.
So NWBO diehard longs fantasy.
What is not true, has NWBO filed a request for approval with any RA?. That's great news do you have a link to prove that? Ooh, you dont have a link. Thats too bad.
The 21st Century Cures Act. is a fantasy mirage of die-hard NWBO fans.
The EMA is never ever going to approve cancer treatments that the FDA approved without judging and weighing the data themselves. Ever. Moreover, each of the 27 member states will not reimburse any cancer treatment of the EU commission for drug approval has not approved DCVAL L and they will look at the data.
In other words fantasy. Especially since the FDA has proven itself to be corrupt over the Aducanumab incident, the trust between the EMA and FDA is gone. Not going to happen.
In cancer its not going to happen without a P3 trial. The stakes are just too high for other BP.
Anyway, since NWBO management for some reason 2 years and 2 weeks after data lock still is, as far as we know as of today, outright refusing to file any request with any RA for DCVAXL MAA what the hell are we talking about other cancer indications. Laughable (no offense)
everyone is entitled to their own "soon" Doc happens to perceive soon as in 8-10 years which in the bigger scale of continents moving is not that far off
you obviously dont understand how RA approval works. If a biotech or big pharma thinks it can improve the treatment of a medical indication by new technology as you describe they need to prove efficiency and bring evidence of the efficiency of that new technology for each medical indication. DCVAXL will be approved for the treatment of GBM in case you have not noticed not for other cancer indications such as lung or liver cancer of any kind. For cancer in other organs, new P3 trials have to be started. Anyone who thinks that based on DCVAXL data NWBO will gain approval for other cancer indications outside GBM is living in a fantasy.
Live and learn the basics of biotech.
If it it’s up to NWBO management count normal earth time x3-4
NWBO, or the company buying NWBO, will have to start other P3 DCVAX trials for other solid tumor organ cancer indications such as lung, liver, prostate etc to prove efficiency and then submit the request for approval.
At the phase the request for approval for GBM is going we are looking well beyond the 2030s for other organ cancers
The relevance is, is that NWBO is a horrible lead company, that does not gives a sheut about its shareholders and progress and therefore does not give a rats about urgency and with that the faith of GBM patients. Thats the relevance.
nope NWBO will make it because of the outstanding technology of DCVAX L despite LP and LG many blunders and screw-ups. DCVAX technology has provided inept management with tons of hall passes (read new finances for do-overs).
A blind and lame monkey could have gotten this over the finish line better than management.
"I'm not arguing whether submitting an MAA is a material event. I believe that the company considers it to be."
well I have Les heard calling his dogs part of his family, I would argue they are biologically not ;) lol
one of my best friends is a securities lawyer with a prestige law firm. He said that submitting the filing of a Marketing Authorisation Application for a medical drug is NOT a material event. The decision on the application, of course, is. I can not control LG's perception of material events, but I suggest he should do a couple of refresh law courses for he has not practiced law for over 20 years.
Now do I believe that NWBO has not submitted the MAA? Absolutely. Why because that would mean progress and progress is something turtle NWBO hates to make.
I do believe NWBO would PR the submitting of the MAA with the MHRA but that's again not because its a material event. I suggest you do some Googling on what material event actually really means especially in relation to biotech companies.
filing an MAA is not a material event doesnt matter how NWBO considers it. Of course, the decision by an RA on the request for approval of a drug is.
aah another kick-the-can argument. Yes nothing for years but a new shiny thingy at the end of the next rainbow.
lol if NWBO management was so dam sure that shareholders would vote yes on the ASM to avoid as you say any shooting of any bodypart then they would have held the ASM already without any news but with the vote to increase A/S. In other words, NWBO management disagrees with you.
Correct that’s what I’m saying. I’m saying that despite LP and clown LG DCVAXL will make it to the market. The succes of the drug can be contributed to Bosch Ashkan LL many external consultants and some others in the BOD. LPand LG are responsible for a good 7 years unnecessary delay, x2 unnecessary dilution, x3 creedy reward and exceptional self dealing (Advent). I hope and suspect LP and LG will loose the true up law suit and have to reimburse 50%/75% of their NWBO shares/warrants and option.
seriously let me help then. This management SUCKS and is incompetent beyond being incompetent. Im holding waiting for this bunch of losers to be bought for the science.
Flipper was in that message you responded not complimenting NWBO Mr Doc
at this point, I would be over the moon happy with the publication of the JA in Mickey Mouse Magazine.
I dont know perhaps
https://en.wikipedia.org/wiki/Lead_validation
Lead validation is the process by which sales leads generated by internet marketing campaigns are separated from other types of conversions. Lead validation ...
She is new
https://www.linkedin.com/in/joanna-bacon-55548122/
Joanna Bacon
Validation Lead at Advent Bioservices
So a lead manager occupies herself with new clients of course other than NWBO
which in turn means that NWBO-funded Advent is now in the business of getting other clients
as soon as you see Advent Bio hiring a sales manager /staff you know we are screwed over
so far I haven't seen any sales staff hired by Advent
https://www.linkedin.com/company/advent-bioservices/people/