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Exactly! :)
What he said! :)
How about some liver?
I sincerely believe that is what they think it means. But as I stated, they've been clear the PR'd timeline is an estimate based on what the publisher anticipates the time to take. Something new could come up, and I'm sure no one (share holders, the company and the publisher) will be pleased if it does.
Awhile back, I, too, thought that might be how the company would submit. But with them PRing their intent to ask for the 150 day pathway, I no longer think that.
lol… :)))
Well perhaps some things can be stuffed back into Pandora’s box. You’re welcome to jump back in there, too. :)
There are quite a few who know exactly who I am.. and I seriously doubt they would let me get away with just making &@%# up.
As I’ve stated, I don’t believe any “parts” have been submitted to the regulators; therefore, they could be edited and improved upon.
“Majority” means enough of the application is with the publisher to initiate their cross checks for:
I don’t think any of this edit work involved the regulators. And as I understand it, once the application is submitted, a large part of it must remain the same for the other three regulators. So it’s very important that this first one be as perfect as possible.
Agreed… that would not be good. Hopefully, a “kick back” was avoided with this additional 2 months of work… that was the intent, anyway.
What’s not happened is that those “parts” were not turned over to the regulator, because once that happens, you can’t unring that bell. I think those “parts” were considered largely completed over the summer (hence the PR indicating a submission by around Oct 15), but the acquiring publisher realized those “parts” needed some rework, and LP agreed. So here we are, two months or so later, with great data, and an improved application, potentially saving many months in the march to approval had the edit improvements not been done.
That’s my thinking, anyway.
CAR-Ts kill off all the B cells in your body. IMO, it’s not particularly surprising, then, that a new malignancy might crop up as it would seem that killing off all the B cells would severely hinder the body’s immune system.
The great thing about DCVax is that it props up and improves the body’s immune system.
A. The application “correction” began months ago… leading to the October 13 PR stating there would be a delay; and as indicated in the latest PR, the majority of the application is NOW in the hands of the publisher, and in several weeks from the date of that PR, the publisher (basically, the new publisher that purchased the first publisher) will complete their part in the process.
B. As mentioned, I believe that the larger publisher who bought the smaller publisher Northwest had been working with were the ones that alerted Northwest to the issues with the application that needed to be addressed.
That is, at least, how I understand the situation.
Agreed. It’s no fun, and very frustrating, but having a bit of color added certainly lessens all that for me. It helps to puts me on management’s side, rather than on the opposite.
Well that’s your opinion, and my opinion is that you don’t have the slightest idea what you’re on about.
I was not that familiar with the company, but I’d read the PR regarding when they were initially rejected and manufacturing issues was cited as one of the reasons the application was rejected.
I don’t change my posts because the price goes up or down as my posts are simply based on my opinion, or what I know or think I know. I really don’t care if the price goes up or down right now. I believe it will go back up when they announce MHRA submission and I fully trust that will be happening sometime soon.
lol... I always am sure to read Reefrad's posts. But for my part, I value good commentary.
Sorry to hear that Reefrad... lots of things to mourn in Israel, which makes your wife's loss even harder.
Heard similarly... only, I think it may have been the consultant's work that was the issue. I believe the publisher was acquired by a bigger publisher, and the bigger publisher found problems with the application, and together with LP and crew, worked to significantly improve the application. I think that issues centered more around the readability and presentation of the data, although don't hold me to that.
Below is an example of Ocular Therapeutics having submitted an NDA application for Dextenza to the FDA whereby their data was great (and later approved on a third resubmission) but the NDA was sent back twice to OT partially due to issues with the application and its presentation of the data. I'm not particularly familiar with this drug, but the two delays held up approval by much more than a year, underscoring the importance of presenting great trial data to the regulators as clearly and succinctly as possible. And that's not to say that the DCVax-L application wasn't readable, but from what I gather, it was decided that it required additional work to make it the best that it could be.
One can argue that holding it up by about two months (Oct 15 to Dec 15?) cost the company an additional XX million to keep the lights on, etc., but if the application was kicked back and held up by another 12 or more months, that would have been far worse and cost many more XX millions to keep the lights on. IMO, it's a good thing that those who think differently aren't running Northwest.
Bear in mind that this oncology treatment is the first of its kind... a truly autologous treatment to be submitted to the regulators. And once it's submitted, as I understand it, the base part of the application will remain the same for all the regulators. So it's very important that the application be as perfect as possible upon its first submission.
Ocular Therapeutics - Dextenza
July 2017
Great advice on your part. :)
No, I’m saying that the neuro surgeons and neuro oncologists in the US play an integral role in determining how a GBM patient is treated. If DCVax-L is approved in the US, these types of doctors will become an integral part of whom DCVax is marketed to.
Agreed... IMO, it's important to remember that these four doctors are also a part of the DCVax-L market, upon an FDA approval. If the company should say anything, IMO, they should do it behind the scenes and certainly not in a press release calling these four guys out. It's possible that what happened is that someone else wrote the article, and they foolishly agreed to sign their names to it.
Looking forward to the day when he has to give some back to us.
For the 100th time over the years, biosectinvester… agreed!
Yes! Hopefully the new year discussion will turn to how long will it take to receive an answer to a filed MAA… 80 days, 150 days, or 150 days plus a clock off.
Thank you, Eagle! :)
Oh… that’s a huge mistake! It’s expected that sometimes investors like ourselves may make mistakes (you don’t make the Lykiri… at least as I recall) when reading a data presenting article… perhaps we’re going too fast or we don’t know the difference between PFS and OS like ex (just kidding, ex… I’ve made my share of errors, too.. it’s just so fun when you make them!), but I do expect more from these doctors. It’s their profession, so they should be very careful when making claims that deride the work of their peers.
Exactly! As you point out… he even asked the question and got the answer! Over the years, I’ve noted (and written it on this board) how he would never mention DCVax-L as a promising treatment when he was interviewed or wrote about GBM and future treatments on the horizon. When he was at NYAS and acting all congratulatory … I thought maybe he’d turned a page, and/or that perhaps I’d been wrong in my assessment of him… but no, I was right… but I really do wish that I’d been wrong.
Sorry… “that you” was intended to read “thank you”! :)
Baxers… that you for pursuing these errors with these guys… did you also point out to them the problem with their lack of IDH mutation claim? They claimed in their article that this information wasn’t given (using the Translational Medicine article as their source, as it didn’t have that info then). But it was given in JAMA… and they somehow missed this.
I’m not sure if it was also noted here earlier on this board that another error with this paper was the IDH mutation issue… I’m assuming that their 3rd “reason for failure” was that IDH was not noted. But many of us will remember that we waited many, many months during Covid for the company to actually obtain that data by testing the tumor tissues, and that the IDH data was given in the JAMA article. It was even noted in the TM article (the interim paper) that the company intended to obtain this data. And yet these four doctors claimed it was not given, even though the patient IDH data was provided in JAMA. From their hit piece article:
Thank you! Happy Birthday to you, tjluke65, too!
Right.. and that work by the publisher has minimally begun “now.”