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Nice post.
After factoring in IDH status, my guesstimate is that roughly 30% of patients receiving DCVax prior to progression will make it to 5 years versus about 4-5% of those treated initially with placebo.
I respectfully disagree and will continue to wish for the effecient path. They had hired Regulatory consultants earlier and an uptick in workload needed to file requires funding. That is when the first of a series of large exercises occurred post-Utah.
For me, the publication once prepared and submitted takes minimal and intermittent effort. Advent had the handle on manufacturing build up in UK, and Flashworks level demand will take time to ramp up to. Hospitals need protocols before they will harvest, etc., etc. They can launch and follow on with Flaskworks up to a year later and it would be fine.
I think they wotjed full steam on filing and got it in by August time frame.
I am in this long either way, but this time feels right to me. Shock and AWE!
I think the BLA was completed in July and the acceptance came in August.
By May, LL had presented the validated hybridization database twice and the SAP design once. There was a big June warrant exercise which could have paid fees and then the package acceptance. If this is how things played out, then it puts February in play for approval which may have opened the door for a coming soon campaign, beginning with the ABTA program.
I am actually feeling like this is building up to a crescendo.
I thought someone posted payment schedules and there was an initial upfront and then ongoing payment. I don’t think we can do simple math to arrive at number treated thus far through Specials. We also do not know if they are providing or applying for financial supports of any kind.
Somone did post an image that looked like Advent supporting insurance claims processing.
Ex, are you telling me that you do not believe MHRA would stop the specials program if they knew the drug didn’t look effective or that they have not yet seen the data?
This is an interesting perspective in my book of viewpoints. I do not know much about the procedural conduct of the specials program. If a promising new therapy no longer is promising, is the plug pulled on the specials voucher? Are you back to the NDA process and clinical research trials only?
What is your reply to this person?
I may be having an age related moment, but can someone give me background on this trial?
I don’t seem to remember anything about it. It looks like a DCVax combo in other brain tumors. I wasn’t aware we had started other tumors, but I do recall approving an ISI for brain mets.
https://clinicaltrials.gov/ct2/show/NCT01204684?recrs=ad&cond=Glioblastoma+Multiforme+vaccine&draw=4&rank=24
Thanks for responding
Doc, what injection video are you referring to? I am not familiar but would really like to take it in.
Scams don’t win court battles accusing them of being a scam. Scams don’t purchase advanced manufacturing technology like Flashworks. Scams don’t get continuous positive comments from US and EU PIs during a self-imposed quiet period. Scams don’t seek approval of revised SAPs before locking databases. Scams don’t give themselves $5 million loans that convert to stock at extremely favorable prices. Scams don’t pay themselves bonuses in stock vs cold hard cash.
I don’t recall seeing any new patent PRs either. It is almost like they are saving as much ammunition as possible for when they finally end their quiet period…
Oh yeah, scams don’t get to run Early Access programs like Specials and get paid for product under those programs.
10b, then I apologize for being snarky. While I am quite confident in my investment and the coming soon campaign belief, I may be wrong about coming soon. But, I am not wrong about my invest Either way and all things keep lining up to support the coming soon idea that I put out here with the bag.
I am m sticking to my approval by end of February prediction at this point. 85% confident, 10% COVID delays this, 5% could be wrong.
So no booths at SNO and ABTA where they had advertisements that met or approached the allowable limit on information shared during a coming soon campaign, but come May the booth is back…
Very interesting, but the full page ad and the registered trademarked tote bag should be put to bed as the saved post above indicates as they cannot be indicative of a coming soon campaign.
Thanks for your confidence 10baggerz…not…can’t wait for my validation
Tick tock, tick tock…rolling BLA…tick tock…May Mt. Sinai…tick tock…August save your tissue cryogenically…tick tock…tick tock…December MHRA certification….tick tock…
Dinggggggg!
Bye, bye shorty
This is a game of billions, not millions
Not every oncologist had access to the data set.
Oilpatch… correction.., very few on the outside have a clue what RA footprints look like.
There are so many footprints here, some of us know quite a bit about what has been taking place (intuitively).
IC-nothing, yet again…I am right and you are wrong.
See also Lykiri for validation if necessary.
My view is that FDA uses Advisory Committees if they are torn about what to do (rarely) or if they are trying to bolster support for what they plan to do when they don’t think the decision would be met well by physicians or patients. Again, what I have witnessed is that they place higher value on patient/caregiver public comments over the AC as well.
Here, the public comment piece is a SLAM DUNK,. So if physicians are on board, no need for a committee. From what I can tell, through whar we all share here, but also through industry friends who actually engage some top neurooncologists, their is no need to bulster expert support either. Those tapped into the development products are full swing eager to get their hands on DCVax.
I will be absolutely shocked if an Advisory Committee is called on for DCVax. The usual case is no AC. With Stuup coming around, the only naysayers are those trying to contain this stock.
We are golden!
Flip, I don’t think people realize the ramifications of the primary investigator and first author doing an about face on a product for a patient sector. Good luck trying to market your product to physicians for those patients. Done diddly done for…
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167476988
Follow the chain and watch the youtube video
No there is no public release requirement, and they do not have to make public the filing or the acceptance of the file, and in fact can prevent FDA from making these public.
Recall the clin trials.gov requirement is enforced by FDA, or not enforced, as they usually handle these things.
Negative data, however, would need to be shared with any new potential research subject before consenting them to receive DCVAX. This is not only US requirement, but International law. Would you be eager to try the combination of two failed products? Or pay £150k for access to just the DCVax portion of the failed combo?
That’s rich, criticizing someone else’s abuse of facts…
That laugh just made my day
Yep, AND I do not see any reason to change my view at this time. I may be wrong or COVID may delay things, but I am sticking to the belief that the BLA has been filed and the buzzer sounds mid-February.
The trademarked, branded DCVAX for brain tumors will be an available personalized immune therapy very soon, as it s safe and feasible to add to the Standard of Care, and all new product research approved by FDA has focussed on the much smaller and treatment resistant market of Recurrent GBM using Hybrid control models for comparison.
It is important to protect your trademarked brand, so your partners must update 9.5 year old press releases to include the registered trademark if they still wish to market their connection to DCVAX.
https://www.izi.fraunhofer.de/en/press/press-releases/fraunhofer-izi-received-manufacturing-authorization-for-dcvax-l-brain.html
Linda Liau and Keymours Ashkan have seen the data and continue to be very positive. In fact, we just learned that KAs UK colleagues in private practice have also jumped on board… now where do you think they got that confidence from?
Thanks for posting…Looks like potentially 9 private hospitals join the offerings of King’s hospital.
https://www.hcahealthcare.co.uk/
Biosect, I agree with what you have to say, but why would you delay approval in order to get Flashworks up and running? iMO you get approval and advance manufacturing afterwards. I hope the end up building out 10-12 maufafturing centers across the US using Flashworks. I hope the do not license it to CRL. That could lead to an eventual competitive platform sooner than otherwise anticipated.
Then why did we spend all f that money building up Cognate? Flashworks is phase 2.
And if you had that meeting about a year ago, do you think it would take you over a year to submit your BLA?
Publication and regulatory pathways are COMPLETELY unrelated. Those that believe that they are waiting to file because somehow journal editors lend credibility or provide pressure to FDA are living in an alternate reality. Regulators don’t give a damn about what publication editors have to say. They operate with full view of every last detail, not just the summary tables presented to journal editors.
This is one that likely will not require an external Advisory committee. My money is on them making this decision on their own.
This morning, I am appreciating this journey and know what the ending will be…
MasterBlaster, I do not disagree that the capacity us 14k retailers can handle has been close to exhausted.
How many of the 325,000,000 warrants exercised over the past 2 years actually hit the market with a sale?
To put context to that situation, those shares netted about $80M for the company to spend on top of the loans also taken out. The share price after that dilution rose along the way going from about $0.25 to $2.50, then dropping to $1.60 before rebounding at $2.15 then slowly drifting down to $1.40 before plummeting to $0.65 once again. That roller coaster still nets us at a nearly triple gain, but a 4.5x gain in Market Cap.
Of the warrants that hit market how many went into the hands of longs and how many to traders? How many new hands?
If you can give me a reasonable idea on the answers to those questions, then I can understand demand better. It is the spikes that were telling…
LP -> Data Lock -> Investment article.
LL -> Message Board Hype -> ASM/ASCO
Those tell you a lot about potential demand.
I have been trying for the life of me to think about what news over the past 12 months has driven the stock price down from $2.50 to $0.65 and all I can come up with is good news.
I mean ATL here posted a pretty comprehensive review and believe it or not there was even more added in from several angles that ATL did not include.
But there is no way this stock has been manipulated down…no way.
Can you even imagine what it would be like to get TLD in the next week and a half, kicking off a succession of heavy hitting PR statements?
Boy, oh boy, I hope you are right!
Captain if I am right about placebos being move to treatment before progressing, and them getting removed from placebo group, then the placebos are enriched with deaths who did not crossover. 30/99 < 30/79.
This would have a beneficial impact on the likelihood of statistical significance in the original mortality analysis.
You could also censor them at the time they crossover which still substantially hurts placebo group.
Very helpful background. Thank you highwayman
Highwayman, If you understand how Orbis would be applied, I have a couple questions.
How important was MHRA certification to an Orbis project?
Is it strange that Cognate (US and Canada), Advent (UK) and Franhouffer (Germany) all be mentioned in a recent 10Q about manufacturing?
It sounds like FDA leads the collaborative project, is that accurate?
Would SAP submission be coordinated and approval from all four expected or can there be more than one SAP?
Does SAP approval in two jurisdictions indicate likely approval by all 4?
How long does Orbis take once the applications are complete?
When comparing Mar 2017 KM curves to Nov 2018, you can clearly see that the difference between those two curves starts around 2 years and continues growing through 3 years. I assume that separation continues growing until leveling off around 4.5 years.
Because the last 32 patients went on drug, and placebos all likely crossed over after the Aug 2015 halt in placebo meaning the last 3 months of enrolled placebo probably crossed over to DCVax before progression, the people marching from 1.5 to 3 years in 2017 to 2018 were highly enriched with DCVax. This is supported by the 85% treated number growing to over 90% in this time frame. This means that there is a high probability that the difference seen year 2 to year 3 is attributed to this enrichment at enrollment and over the past few months of non progressors.
What was the Intent To Treat those that crossed before progression and which arm do you place them in when analyzing the original cohorts if at all?
It wasn’t a mistake that switched their spots, it was the intent to move them to the treatment group. Those are questions regulators probably debated.
The original data set may be 232 vs 79 or even possibly but not likely 252 vs 79.
Gary, There are questions for me which drives this number.
With three quarters of data, but only two reported, will they provide us number of patients in addition to revenue? How quickly can institutions change protocols to allow for tissue to be properly packaged and sent out (Did LL’s call to arms get anyone ready? I am guessing no here)? Will we get all four reg approvals in Q1? Is there a partnership or take over?
My guesses are, yes, about 2-3 months in most cases so it will be a slow start, No again, yes, and partnership.
My answer is… We spike much higher, then fall, then recover ground so that 1/1/23 we start at $14.75 with momentum building throughout that year.
I would be curious as to who owns the rights to those SOPs and validation processes. My guess is NWBO.
I try to look for other small, but growing biotechs for my comparisons. A company like INCY has a growing product portfolio with increasing revenue, currently running just shy of $3B in revenue. They hung around $18B before a year end drop. Their pipeline has some promise and revenue should grow from recent launches.
If you figure $250k give or take and US SOC that hives you about 8-10,000 cases per anum and figure closer to 5-6,000 other countrymen. They would price lower figure $175K on average, then I would say $3B in revenue is achievable faster than you think and licensing and pipeline and indication expansion gets you much further than INCY. I am guessing a rapid acceleration followed by a short squeeze spike falling back down to a reasonable near term number. Then an explosion as revenue rolls iin and several indications start trials.
Ionis basically structured itself in the way you are suggesting. They sold disease state rights for antisense development to a variety of biopharma. They launched one themseleves and have partnerships that prevent them from being taken out.
This is old school biotech, back when the start ups made deals for cash instead of selling a bunch of stock. They tried to lock in three or four deals with poisen pills that made anyone takeover lose a bunch of assets.
Preclinical Gene Editing Data on its ARCUS-Based Chronic Hepatitis B Program at the HEP DART 2021 Conference
In this preclinical study, ARCUS efficiently targeted and degraded HBV cccDNA and reduced expression of HBV s-antigen (HBsAg) by 77% in HBV-infected primary human hepatocytes. To evaluate ARCUS in vivo, mouse and non-human primate models were developed that utilized an episomal adeno-associated virus (AAV) containing a portion of the HBV genome to serve as a surrogate for cccDNA. In both episomal models, a robust decrease in AAV copy number and high on-target editing in remaining AAV was observed, and a durable 96% reduction of HBsAg was further observed in mice.
See page 37 for abstract.
https://static1.squarespace.com/static/5c912d7af8135a45d18dd805/t/61aa80a73f24a36f20f71eca/1638564010806/hepdart-2021-abstract-book-final%5B26%5D.pdf
Thanks for posting, JonDoe. Although this looks like an exciting potential enhancement, it seems pretty far off at this point. My guess is that there is still animal work to be done before trying tuis in humans. Do you gave any idea of the stage in development at thus point?
It is quite exciting to see how engineering can be employed with the ability to genetically modify in or out. Add these kinds of improvements to the stealth advancements and sprinkle in multiple antigens and CAR-Ts are here to stsy. You know I love the dendritic cell vaccine technology, but the two don’t have to be mutually exclusive. Cancer treatments are about to take a giant leap into the future and CAR-Ts have only just gotten started.