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You’re insane and wrong.
Welp, to my knowledge, the next sliver of news
will be on May 31. Laura Posner response to MTD due.
I just go back to common sense. At this point, if I were in management’s shoes, there is no way I’d go into an ASM without at least one major (truly major) news item to discuss, which might be released sometime prior to said meeting. IMHO.
Thank you. Great DD.
I see, and you are assuming NWBO received a judicial order, when they mentioned nothing about it in their 10k even though mentioning end of June ASM likely.
Um….I was talking about the MTD decision, dummkopf.
Theoretically, a magistrate decision on MTD could come down prior to June 29, but that would be fast.
Hypothetical
Day 1: January 24
Day 80: April 13
Day 106: May 9 NWBO still in dark about whether RFI will be issued by MHRA? Les goes on BB and guesses most conservative timeline possible. 150 + 120 gets you to fall?
Day 107: May 10, NWBO finds out no RFI, and 10K is issued but no word to public on timing, other than validation passed on January 24, and confirmed March 7?
Day 119: May 22, Proxy comes out announcing ASM June 29.
Day 150: June 22 (Monday is June 24)
Day 157: June 29 ASM
This is primarily speculation.
I like #1.
Hypothetical: Why would a pre-revenue company want a work week between MHRA approval decision announcement and ASM meeting?
Why would a Senior Vice President, General Counsel want you to think it was happening in Fall instead of late June?
January 24, 2024 (Day MAA “passed validation”)
Added 150 days
Result: Saturday, June 22, 2024
June 24 = first business day after June 22.
June 27 = fourth business day. (Thursday)
ASM: June 29, 2024 (Saturday)
I didn’t ask about NWBO. I asked a simple question about their process. Maybe they have been inconsistent and don’t want to get pinned down.
MHRA so far not replying as to whether 150 day clock starts.
1. Upon receipt of valid MAA,
Or
2. Upon MAA passing validation,
Or
3. Upon MAA confirmed validated.
I’m starting to wonder if they even know.
They say that the request not to transfer by the litigants was blinded, but come on, everybody knows it was Defendants, imo, that rejected court economy. Defendants delay delay delay.
I kinda forgot I wrote this, and I’m not as old as Trump/Biden.
Still, it seems this stands up when I read what I mostly forgot I wrote.🙃
Welp, Wednesday, we get a sliver of news from the spoofing case. Will the trial be handled by just one magistrate, or will the magistrate, judge, highway department, makeup studio and catering be included?
Fancy way of knocking NWBO.
Let’s try this with the sun.
It’s highly unlikely the sun will rise tomorrow? I’m merely speculating, but clearly time and space itself can’t hold a body that massive indefinitely? I’m suggesting, of course, that there are insurmountable problems preventing the sun’s capacity to rise tomorrow.
Still, people on this board will set their alarms, tend their gardens and even purchase sunscreen as if everything is peaches and cream.
A lot, imo. Particularly when 5-ala used during surgery.
Correct.
Ex, regarding SOC, if DCVax-l approved for rGBM, it will replace any SOC for rGBM, as a monotherapy.
Would you stop copy and pasting recent posts with no context for why you are doing so?
No, they are talking about therapies already approved elsewhere (like the U.S.) but were awaiting the standard first mhra assessment national review pathways.
The IRP national applicants left the standard national review and went to the IRP national review.
That reduced the queue in the national review assessment process DCVax-l is in.
Tell me how the mhra are going to recognize another (international) regulator’s approval if DCVax-l has not been approved elsewhere?
That is not the route DCVax-l is utilizing.
Probably like many others, I have requested the mhra answer which of the following triggers initiation of 150 day evaluation:
1. Receipt of MAA (Invoice provided to company)
Or
2. Being informed MAA passed validation.
Or
3. Being informed MAA validation was confirmed.
NWBO is not requesting IRP at MHRA, because they are not commercially approved in some qualifying country.
What DCVax-l’s approval process benefits from is that there are less IRP candidates left in the national process, which means the backlogs dropped.
You just said two opposing things.
1. You believed no rfi from phase 1.
2. Linda was busy answering rfi during phase I.
Can you tell me how you distinguish these, as I believe the standard rfi comes at the end of phase I.
For reference, here is what the mhra says.
Blessings.
Ah, I see.
“Clients” ???
Blessings. My mother calls dogs little angels. They give us so much in their brief time here. I know how hard it is to lose a companion animal, my sympathies and hope that memories keep you and yours warm. If there is a heaven, he’ll be there, or another life awaits you, he’ll be there.
OMG, you are back copy and pasting old posts with no context.
I disagree with your statement below if you are stating they need a C suite to get an approval decision on the original MAA.
Just checking in today.
Bigger going off on AF. I’m thinking Bigger may have been released from nda restrictions.
Hoffman pontificates on very conservative timeline, then admitted he doesn’t know when clock started.
Went back to Q to look at true up case status, and just as I thought, it’s still in discovery. People on this board discussing possible court decision on that before end of June ASM are delusional.
NWBO’s case against MMs, on the other hand,
Could receive a MTD magistrate decision, one way or the other, sometime around but probably after end of June ASM.
Reviewed 10q yet again to see why (a day b/4 10q came out) Les thought it might refer to a fall maa decision timeline, but instead, I still come away with mid-July, imo. There is nothing in it that suggests Fall. Clock started at receipt of valid maa, not confirmation. (It appears though that Les, Hoffman and Ex want people to believe differently. Strange bedfellows)
Imo.
Either way, phase II likely wasn’t skipped in this case. Have a good couple days…. If required.
Here’s what I think, and I’ll be off the board for a couple days.
IMO, Les thought there was a chance they might need to file an extension request to answer an RFI. He said they’d talk about “fall” a day later in the 10q. The 10q mentioned NOTHING about fall. Therefore, imo, their contractors did not need to file an extension request. Which means, imo, we are looking at somewhere around mid-July for a decision. (60 days earlier then Les thought) imo.
I think this because Les should have known what was in the 10q unless it was subject to change in the 24 hours or so after he spoke. He didn’t know, therefore I think they decided not to ask for an extension at some point after Les spoke.
Further, it seems they were already anticipating inspections by the 10q, but such inspections were not scheduled yet because, imo, an RFI response was turned in shortly before the 10q was filed, so phase II had not started until that response was filed. Therefore, it makes sense they’d not yet know when any inspections would occur. IMO.
Finally, if I’m right, it’s very positive, because NWBO and their contractors not asking for an extension would be very unusual, for them, and yet extremely confident.
Ignoring Les, and taking FeMike’s reading of the 150 day guideline, what does the 10q tell you if no RFI required.
We are deep into the final phase of evaluation and not one inspection was scheduled as of May 10th, which is 140 days into the process.
According to ChatGPT, inspections are not always necessary.
Why would Les come in and talk about “fall” for an approval decision if the above were the situation. He wouldn’t. Its illogical.
If you don’t feel phase II of the process was/will be required by this point, you are in the minority.
I do think that’s their belief. Whether you question it is another matter. It’s still good to know that was still their belief on May 9.