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I'm long 13+ years and as eager as anyone for success. Sometimes in their eagerness, people see what they hope to see when they read something like the new MHRA guidance on clinical trials. I get that. But these types of misreads, as they are repeated, quickly become gospel. I suggest people go to the source and read and decide for themselves what is being said.That's they only reason I decided to comment on Mav's post.
See hoffman post 626513
It would be great if this applies to us, but, when read in the original context you posted, it specifically refers to Clinical Trial Registration. It does not mention MAA.
The function and purpose of MHRA advisory committees
The Commission on Human Medicines (CHM)
The functions of the CHM are set out in regulation 10 of the Human Medicines Regulations 2012 (as
amended):
• to advise Ministers and the Licensing Authority on matters relating to human medicinal
products including giving advice in relation to the safety, quality and efficacy of human
medicinal products where either the Commission thinks it appropriate or where it is asked to
do so;
• to consider those applications that lead to Licensing Authority action as appropriate (i.e.,
where the Licensing Authority has a statutory duty to refer or chooses to do so);
• to consider representations made (either in writing or at a hearing) by an applicant or by a
licence or marketing authorisation holder in certain circumstances; and
• to promote the collection and investigation of information relating to adverse reactions to
human medicines for the purposes of enabling such advice to be given.
Full Text
In making the case that CM is making here, what would be much more persuasive would be if NWBO submitted the MAA to MHRA on Monday, the deadline for inclusion in the November CHM. Coming on the heals of Cohen Millstein's response, it would be a knockout one-two-punch. Here's some information on what happens in that meeting of CHM and the 150 day review: CHM Link
Each time I choose Classic, after I read one post it reverts back to the new format.
Return to classic!
Q: When is Cohen Milstein's response to the MTD due? Is it tomorrow? TIA
What’s odd looking is breaking down several 5000 lots into 1&4k. Why?
Lather, rinse, repeat
More from ChatGBT: I asked "How can I learn whether an MAA has been fiiled with MHRA?" I haven't been able to get onto the MHRA Products page since I got this reply on Saturday. I get an error. I post this reply just to see where it may lead. I can't speak to whether it is accurate. For one thing, it has the MHRA URL wrong.
OK, so as expected it doesn't have Murcidencel in it's data base yet. It said there was no product Muricidencel - keeps spelling it that way - associated with NWBIO or anyone else, for that matter. I explained that it had been known as DCVAX-L and asked this time for it to create an ad geared toward doctors.
I used Dcvax because the AI seems to be at least a year lagging. But, I’ll try it.
I asked Chat GBT to create an ad for DCVAX-L just for kicks.
And they neglected to change the 2022 date to 2023. Unbelievable.
I sent @ Zeeshan Aleem info about the Citadel, et al, suit after seeing his article on K Grifffin's donation to Harvard and why it should not be celebrated. He is an MSNBC writer/editor.
Yes, true. But what i wrote is accurate. Read more carefully before you react.
The 4/10 date is not a filing date. This date is updated anytime a user of the RECAP extension downloads from the site.
April Fools!
The oracle speaks in riddles. Simple riddles, at that.
Just a point of information:
MIA = Manufacturing and Importation Authorisation
MAA = Marketing Authorisation Application
MA = Marketing Authorisation.
From franknez.com/citadel-has-a-long-history-of-market-manipulation/ https://franknez.com/citadel-has-a-long-history-of-market-manipulation/" rel="nofollow" target="_blank" >https://franknez.com/citadel-has-a-long-history-of-market-manipulation/[tagLink[/tag]
I’m loving ChatGPT!
Q: May MAA be submitted to MHRA in stages?
“Yes, a Marketing Authorization Application (MAA) can be submitted in stages to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. In fact, submitting an MAA in stages can be advantageous for both the applicant and the regulatory authority, as it allows for a more efficient review process and helps to reduce any potential delays.
For example, it's common for applicants to submit a "rolling submission," where parts of the MAA are submitted as they become available, rather than waiting until the entire MAA is complete before submitting it. This allows the MHRA to begin the review process earlier and can help to expedite the overall process.
However, it's important to note that any submission should be complete and provide all the necessary information and data for the MHRA to make an informed decision. The applicant must also provide a clear plan detailing their intention to submit data in stages, and must be able to justify the reasons for the staged submission.”
That explains it. Thanks.
Is this 'Q & A ' taken from an email response from someone at MHRA, from an MHRA guidance page or someone else's research?
I'm scratching my head at this. Anyone? :
Motion to Dismiss LINK
I agree that it's more than possible that MHRA had informed the company last week. However, I think also that there may be some protocol or understanding that the company will not preempt MHRA with the news of approval. It's too late in the game to tick agencies off, IMO. And, actually, never a great idea. The important thing here is that we have approval.
It's MHRA who issued the update. I'm sure the market is not on their mind. However, tomorrow could be interesting. Very interesting. I'll also add, that as of this time as far as I can see, Citadel has not filed - today being their deadline as imposed by the judge.
Missing jigsaw piece in place! MAA imminent! Advent will be making some really good grapefruit juice now!
Company doesn't even have to. MHRA will post it on their site. NWBO MIA status
She's been working with NWBO since at least 5/21, just FYI.
I just want to throw something in, though it may have been suggested in previous posts. It's my understanding that NWBO can approach each MM separately, meaning NWBO might settle with some of the lesser MMs and go through to discovery and potentially trial with the larger. If they did go this route, they could glean some cash in the shorter term and wait for the big payday down the road. It's in discovery that things will really start to get interesting. To project a settlement price from the current vantage point is folly, IMHO.
Get over it already.
On this listing from Zoominfo, GZ is listed as an employee of NWBO a/o 12/23/22, the latest.link
LP and LG are two very accomplished attorneys. Why noy let them make the decisions regarding legal matters? Is it possible they are intentionally not broadcasting the lawsuit?