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Right… “receipt received.”
I’m familiar enough to state that I absolutely don’t anticipate a company PR announcing a validation of the application and that I think that the board would benefit from moving on from this topic. But you do you, if that’s the direction you want to go.
I’m okay with that.
I don’t mean to, I’ve just been busy with other stuff. I wanted to try and let you know that there won’t be a PR coming out announcing some sort of validation as that’s already taken place.
Excellent work! As I noted, I started researching the same thing, and found the same thing, and was about to post about it (lol), when I finally saw your post. "Great minds...", well you know the rest. :)
Lol... I just started going through your list in detail, and was finding there were no PRs with those headlines, and had gotten through to the fourth (Aeglea Bio - Pegzilarginase) only to find that Hoffman had already gone through the entire list and posted it!
However... I went a bit further than Hoffman on the first four and found that for Aeglea, a "Validation" PR had indeed come out, but it was for the EU and not MHRA. Your headline read:
It’s my understanding that when the DCVax-L MHRA application was filed (back on December 21), this was done after the company had received confirmation (a simple receipt from the MHRA) that the application had indeed been received. It’s just a receipt… it’s the “validation” of which you note…. something like what the SEC provides when a filing is made on Edgar.
The company then announced their filing of the MAA with the MHRA, received their "validation" as you call it (basically a receipt), and that’s the end of it.
After that, the old adage “silence is golden” kicks in and all discourse between Northwest and the regulator is kept private. I believe that the company takes the position that the regulators do not look favorably on any type of public announcements regarding the status of the MAA with the MHRA until such time as something material happens (and that wouldn’t be that the MHRA is in receipt of the MAA).
Therefore, looking for any other type of “validation” regarding the MAA and its application status with the MHRA, and I mean this nicely, is a complete waste of our time because we’ve already been given it. They would never have released the December 21, 2023 PR if they’d not received confirmation that the MHRA had received it. End of story.
Plus… mods can only sticky one post.
Congrats! :)
Your loss. :)
The blocker letter requires that LG/LP give 61 days notice if they plan to exercise (convert) any of those locked up options or warrants.
Merry Christmas to everyone!
And a belated Hanukkah! :)
You’re embarrassing yourself.
I actually prefer the original, unedited post; although ChatGPT did a nice job. :)
Agreed… or at least know what you’re getting into when you go down this rabbit hole.
I believe Kevin Duffy is at Regeneron now… not Amgen. :)
So sorry to hear all this, Smokey! How rough this must be for you. I wish you the best with your treatment, and yes, the Direct trials can’t start soon enough!
I mean, that said, if you want to hold your certificates, or keep them at Computer Share, that’s all fine… it’s just a bit of a chore to get them into a brokerage given they are an OTC stock.
If you ask for your shares in certificates, then you’re taking them out of the brokerage holding them. I asked once… some years back… from Charles Schwab in one of my accounts. Next thing I knew, they were gone from my account and into Computer Share. I kid you not. I never asked for CS to transfer them out. And because Charles Schwab won’t allow the transfer of NWBO shares into their brokerage (you can buy them with Charles Schwab), I had such a hard time getting this situation fixed. They ended up giving me about $1k in credit (I mean, this was all their fault).. so I used those funds and bought more NWBO shares, lol.
Happy Birthday, C.O.! :)
Abeta, you have always been one of my favorite posters. :)
I believe you’ve misrepresented the facts. LP and Cognate were in the muddled of that lawsuit you referenced when Ondra (the PR firm Neil Woodford had recommended) sent Katheryn Wolfe to Northwest to strategize. She asked strange questions and wanted to take home paperwork that didn’t seem relevant to the project. When she left, the company discovered that Ms. Wolfe was on the board of the Israeli company that Roger Smith (who had a Cognate company laptop, not a notebook) was now working for. They felt uncomfortable at that point with working with Ondra, but not necessarily with Woodford who’d recommended them. Of course, within a month of that unfortunate occurrence, Woodford wrote his letter to the company making it public via an SEC filing, indicating his concern over the Phase Five report, which prior to that point, had been given no traction. This account may help give more color to your assertion.
Ex… you’re the one who doesn’t understand. :)
What’s wrong with that!? My gut has served me well! :)
The clock definitely started with the last PR. My gut tells me everyone is working furiously ‘round the clock, (much like Santa’s workshop) to try and pull off an MHRA submission ASAP… first by Xmas and if not then, by EOY.
Last Wednesday marked three weeks from the timing of the last PR, so we are now fully into “several”. There’s also that “CHM Meeting” date requiring a submission date of 12/25 they’re likely trying to meet to add to their incentive to make this submission happen.
Double yes. :)
Fingers crossed… although the company indicated that it’s in the hands of the publisher, who is likely working very diligently to make deadlines. Unexpected things do happen, especially to Northwest, so all we can do is wait and hope that this time, they can file the application within their anticipated timeline.
As I’ve indicated before, before the end of the year is likely… as for this week, who knows?
My gut. :)
“Everything” would mean the remainder of the one key section of the MAA package that was already almost completed and mostly delivered to the publisher/QC team by the time of the last PR.
But everything is in the hands of the publisher at least a week ago.
Mama also said…
Agreed.. although for my part I’m confident that the company is still strongly hoping to submit the application by the end of the year, if not earlier.
My goodness… how deep does this posting go? Lol… I just stumbled onto this tortuous thread.
I’m confident that it’s a fact that the initial publisher was recently purchased by the bigger publisher.
I’m confident that what flipper has linked that I wrote is as close as the company’s take as it can be, give or take some sort very minor misinterpretation. And so hopefully this post can put an end to this thread.
IMO, at least this time, I believe that for the company’s part, several means two to three weeks. But as Doc Logic pointed out, as did the company, the timing has moved into the publisher’s hands. One would think that the bigger, more experienced publisher will be trying their best to wrap this up in order to get it into the MHRA’s hands, and be better able to pull that off. Especially if they know your ability to post is on the line. :)
So for my part, I’m very much hoping it’s the application is submitted by sometime next week, but if they need another week or two, it’ll likely be for good reason.
Alpha puppy.. the primary endpoint actually had been PFS, and OS the secondary endpoint.
It was intended that the surrogate endpoint of PFS would allow the company to request accelerated approval and that OS would be the confirmatory endpoint.
All that changed when they created the SAP (statistical analysis plan) while still fully blinded, in 2019.
3 years after data lock… not 4.
I can see them in my desktop… but not on my phone.