No. NWBO paid consultants (Cognate and UCLA) to figure out how to make it and the process is available to UCLA who works with it. Any changes to the process are owned by NWBO due to prior art patents.
It is the same ridiculous argument you guys put out daily. Even LL stating in a presentation or in writing that ALT-DC is DC-Vax cannot stop you folks from this FUD. Really willfully blind.
Keep in mind he has accused those MDs of medical fraud and malpractice as well- which I expect will come back to haunt him in relatively short order. :)
They probably want to cover....Our days of sub 0.90 are just about over...
FID dropped the borrowing rate from 39% to 35% so it appears there is less demand for shorting...If they are smart, they would cover.
Ex already laid it out for you numbskulls. L is proprietary. If ALT is L than everyone in the world knows how to produce L. PERIOD
Hahahaha. This is fantastic analogy. Fudster-delusion should now be called fudster-coon from this post. Nah, I will stick to fudster-delusion. It is more fitting.
Ex does not even believe visual photographic evidence...so why accept the true words of two MD's involved in the studies, when it does not meet one's narrative.
I would hope that we all understand that while we're in the period the company forecast for filing, there would be no cost to the company if they missed by a few days, and we should understand that. I believe that they'll be on time, but the key is getting it done right, not quickly, so if they are taking more time to be more certain, I can live with that.
Acceptance of the filing is never a guarantee of approval, but I very much like our chances of getting that on the initial submission. Anyone who's ever invested in biotech's needs to realize that regulators often ask for more before approving, and more can be anything as simple as answering a question that they already have an answer for, to running more trials. I believe the UK wants the vaccine to be available and won't delay it, but when it comes to dealing with regulators, nothing is certain until it's done.
I'm a Pumper Hunter...a Boiler-room coon sniffing out your hustles for finders fee g's.
My prediction...7 days after submission...or less.
From memory, the MHRA goal for time to acceptance decision following maa submission is 14 days or less for approx. 97% of submissions.
That’s my memory.
Fudster-extraordinaire is now competing with fudster-delusion in inducing sleep with posts.
LC is a paid basher. It is questioning tactics. He’s trying to hunt out if there are any paid pumpers.
Copy and paste from a web page works also. Merci à toi.
Is submission to acceptance done within 14 days? I read something for medical devices that submission to acceptance was 5 days.
So Dr. Liau is mistaken. Dr. Prins, who stated NWBO has nothing to do with the trial, stated UCLA has “had our own IND for this vaccine”. So when he said “this vaccine” he really meant another vaccine? Both these doctors but you are right?
The trademarked term is DCVAX-L. The trademark name is not listed on studies. For example, why isn’t Keytruda listed on the study? Are you going to say Pembrolizumab and Keytruda are different? Or did you figure out that they don’t use the trademarked names on studies?
Hi Doc, you're welcome. Realized my initial response was insufficiently clear. Just found these two listings of Alt Codes. Not all work as codes have changed over time. All the best.
Was leaning acceptance but now submission.
...And, the reason pumper soldiers here refuse to get to the bottom of it by making a simple request to the company for clarification.
"And there is a reason LP/NWBO will never discuss the subject. Because if they say anything then they must disclose the truth"
He's saying we're in the 30-45 (15 day) window they provided us, which we are.
Can never trust regulators aren't in someone else's pocket. We have come this far why not wait a bit for acceptance if you expect it to follow quickly.
Nope not 15 days. 11 days
I believe that there are a few different protocols where the regulators work together in which the rules prevent companies from saying that they are working within the protocol. While it's in no way certain, I believe that we are in one of those protocols.
The fudster-extraordinaire has clearly been hamstrung after the publication of the JAMA data and is resorting to repetitive nonsense on ATL DC, aka DCVax-L. There is a reason why he is repeating this fud. That's because the published efficacy of the combo treatments in which ATL DC, aka DCVax-L, is the common ingredient, would show him the door.
I second you; Submission PR is first, followed by Acceptance PR in 14 days; the MTD update in the next 14 days. These are in the calendar already. Anything else like FW readiness /Combo deal updates are in the radar, imo.
I think they will do both. After all this time, they would never submit without knowing acceptance will follow quickly. They have been working closely with RA in UK for a long time.
The manufacturing process used for the Poly-ICLC combo trial is public and it was clearly not the same as DCVax-L. Multiple manufacturing batches per patient. Different maturation times. Different times when the agent was frozen. Use of subsequent leuko as needed. All different from the NWBO "one batch per patient" process.
If LL wants to say they are the same, fine. At a very basic level they are. And by her standard so would be other ATL-DCs like the the already approved APCEDEN.
There is a reason why it does not say DCVax-L on the ct.gov site. And trademarks have nothing to do with it. And there is a reason LP/NWBO will never discuss the subject. Because if they say anything then they must disclose the truth.
They have told others they would submit acceptance as well. Any followup requests for clarification were met with cryptic responses. I think they are unsure. IMO they should wait until acceptance because if they botch submission, PR submission and it gets rejected, they will likely have to 8k the rejection. Do not know for sure just a hunch.
I am not pumping. I am talking about the fact. Let's see how we close; I expect FOMO setting in any minute now. We are in the 15 days window of the MAA filing.
CassieW, don't be hasty in your decision not to read LC's posts. You might find them useful on a sleepless night. His boring posts are a sure-fire cure for insomnia.