Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The NHS ring-fences funding for certain classes of medicine that receive a particular type of recommendation from NICE.
The Cancer Drugs Fund (“CDF”) is in place to enable faster access to promising new cancer treatments. Following its relaunch in 2016, the CDF aims for all new systemic cancer drugs to receive a fast-tracked NICE appraisal. So far, 102 new oncology drugs treating 242 different indications have been through CDF review. NICE will recommend a product to receive funding from the CDF, at a negotiated price, if it has the potential to satisfy the criteria for routine commissioning but there is clinical uncertainty that needs further investigation (i.e., through data collection in the NHS or clinical studies). The drug will remain available within the CDF while more evidence becomes available, at which point NICE will subject it to one of its standard technology appraisal processes. The CDF has provided a route to NHS funding for a number of highly innovative, high-cost oncology technologies, including CAR-T and certain immuno-oncology therapies. The NHS has guaranteed £340 million per year for the CDF.
Introduced in 2022, the Innovative Medicines Fund (“IMF”) is an analogue to the CDF for non-oncology medicines that show significant clinical promise but for which the evidence base may be immature or uncertain. The primary function of the IMF is to provide managed, interim access to a promising medicine to patients while further evidence is generated to support a full NICE assessment. As with the CDF, the NHS has guaranteed £340 million per year for the IMF.
I’ll have to write them as well since you are not going to answer what your precise question was.
I did not say a partnership deal was already done, but I did state that NWBO intends to proceed with financially beneficial trial combos with several parties once the maa is “cemented.” According to LP at December 2022 ASM. Read the transcript.
I’ve already responded to your misworded second question multiple times.
I was incorrect on your third question. One does not always need to file an MAA before a commercial MIA is granted. However, I was right that Advent utilized the DCVax-l manufacturing process to prove their facility was entitled to an mia.
What was your precise question?
Correct, there may or may not be an RFI issued. The company stated just after submitting the maa that they anticipate an RFI will be issued, probably because that is most common.
What was your precise question?
They don’t have to PR if there is an RFI, as far as I understand. If there is one, it could be easy, moderately hard or difficult to respond to. Meaning, they might need a few days, a few weeks or the entire 60 days to respond. If an RFI is issued.
I think we (longs) are all hoping there was good coordination with regulators through our consultants prior to submission. This coordination is suppose to be easier because this is an orphan indication.
Because you need a response to start phase ii, so they can conduct their assessment of your response. However, if no issues, no RFI and therefore if no response, you can’t start phase II assessment, because the assessment is complete. Therefore, determination. IMO. See my prior points from today for more.
No. I’ll stand on my points from today.
“Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.”
And RFI’s are not always “necessary.”
Poor thing. Always evading reason.
Newsflash, everyone except apparently you has known about the possibility of 60 days clock off for quite some time. But it’s amusing to see you think otherwise.
No, I’ve explained it to you. You simply don’t understand logic.
If an RFI response assessed in Phase II meets all issues raised in phase I it leaves assessment, because it is “complete,”and goes to determination. (According to the recent MHRA newsletter and link on established medicines)
If an RFI was never issued because no issues were raised by MHRA in phase I, then it is “complete” and needs no further assessment. Meaning it would go to determination.
Imo.
You are just repeating yourself. Go back and read my arguments. Read them all. Don’t pick and choose.
Long story short. You and ex think this has to add up to 150 days of assessment. It does not. It can be less. In some cases far less. In some cases no further assessment is done after phase I, just determination.
It’s sorta like:
Prior to JAMA, shorts thought they were playing chicken against a ford fiesta.
After JAMA, shorts thought they were playing chicken against a Camry
After submission, shorts think they are playing chicken against a Ford f-150
After March 21, shorts will think they are playing chicken against an 18 wheeler.
You simply can’t respond to reasoned argument with facts. So you just say stop making stuff up.
Here is your game. You want a vulnerable window where shorts can attack without fear in hopes that you can buy cheaper.
There is no vulnerable window. Time has matured such that many things can occur, and in a couple weeks, the possibility of early approval will be included in that window.
Clarification:
“>” was used as an arrow, not a greater than symbol. Sorry for any confusion.
They are pulling all the IRP from the National case load, and this is massively reducing the case load for National assessment and the review times are coming down very very quickly into this year, for both IRP and National.
You would call the MHRA, not the company, but you don’t need to, because the MHRA neither specifies working or business days for the 150 day process, which means it is calendar days.
Remember, it’s “by 150 days” not “at 150 days.”
If you are correct, take the established medicines protocol. What are they assessing for up to 150 days?
Well, if they do send out an RFI after the first assessment period, when the clock goes back on, they are only assessing the response. If the response addresses all the issues, then the maa moves to determination. If the assessment of the response finds issues still remain, like “efficacy” or “safety,” then it must go to a CHM hearing.
On the other hand, if an RFI is not issued, it goes straight to “determination,” not further assessment.
So let’s review.
Quick route. 80 days assessment > determination
Slower route. (Up to) 80 days assessment > RFI > clock off (up to) 60 days > response received and further 70 days assessment > determination.
Slowest route.
(Up to) 80 days assessment > RFI > clock off (up to) 60 days > response received and further (up to) 70 days assessment > sent to CHM for advice > further assessment > determination
Ok, let’s say you’re right, what do they review in the second assessment (phase ii) besides the responses to the RFI? For the established medicines, the answer is nothing.
The thing speaks for itself, but here, below,is the process for established medicines. As you can see, “technical” validity is determined immediately. Or as close to submission as possible, that is not “Phase I” as you claimed in your last quote I gave. Next, the initial assessment is made, which includes “scientific assessment,” (not in phase ii as you claim). In other words, you were wrong. They do make a scientific assessment, and if no issues are raised, it goes straight to a “determination.” If a request for more information is instead issued, the clock goes off for 60 days. The second assessment begins from receipt of the response. If it is a complete response to the RFI a “determination” will be made, just like it would have been in the initial assessment if no issues had arisen.
We are taking significant steps to assess applications for medicines approvals within statutory timeframes. We will always prioritise applications according to public health need.
From 1 March 2024 we will be introducing a process change to ensure applications are complete on initial assessment, or as soon after submission as possible.
Upon receipt of an application MHRA will check documentation provided for technical completeness. If applications are incomplete, they will be refused
Applications which are technically complete will continue on to scientific assessment and where there are issues raised a single request for information (RFI) will be sent out to the applicant (there will no longer be more than one RFI).
Applicants will have 60 calendar days to respond to the RFI.
There will be three outcomes from this point:
If the response is complete the application will be determined
If the response is inadequate on quality, safety or efficacy grounds, then the application will be referred to the Commission for Human Medicines for advice
If no response is received within the timeline of 60 days, then the application will be refused.
FEMike said:
Phase I reviews the technical validity of the application.
Phase II reviews the scientific aspect of the application.
Show me one place where it says what they do in phase ii besides review the response, if one was required.
FEMike said:
“It will also start immediately after P1 if no RFI is required.”
“Phase II assessment will commence on receipt of the applicant’s responses”
This website is still slow, just not as slow as this morning.
BPs aren’t going to want to run equivalence tests for their separate indication trials, instead they are going to want to start with the closed system automated production* (standardized commercial units), imo.
*(Which may still be accomplished by Advent and possibly CRL)
Considering the possibility of several franchisees for separate indications in deals with BP. I presume the announcements will precede the initial trials by a fair margin, and I expect the deals announced would help fund the trial preparations. Finally, logic dictates the trials would begin (not transition to) with closed system automated manufacturing. Consequently, it is also logical the trial announcements and preparations would build in lead time for NWBO/Flaskwork’s final commercial unit completion, and the preceding deals would help pay for production of commercial units. IMO.
Sensible ramping.
Follow up to Hoffman’s INN USAN due diligence.
Hoffman predicted USAN adopted name (Murcidencel) publication for end of January 2024 based on last year’s successful INN review timing.
USAN publication has not occurred yet, and since companies are allowed to ask for up to a six month deferral on publication, I assume that’s what NWBO did. How much of that six month deferral they’d want, I do not hazard a guess.
Why would they do this? I also won’t hazard a guess other than to say they could use the name as far back as November 29, 2023, based upon successful INN review, according to Hoffman, so I assume they probably used it to some degree in the MHRA maa filing.
Never mind, you are right and FeMike is wrong.
Phase ii is only required if RFI response is required, and an RFI is not always issued.
“Phase II assessment will commence on receipt of the applicant’s responses” — https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
“I just don't believe Merck, Amgen, etc. are building without some solid indication that there is a use for their facilities.” — Ski Tahoe
Maybe you are both correct.
Technically Mike might be correct (they always check off phase I and II.) However,
time wise, very best case scenario if no RFI and no CHM then Crash Crash might be right. Or second best case scenario, after 80 days from validation, they satisfy within 60 days RFI and no CHM then still earlier than Mike thinks, but phase ii still probably gets checked off.
I believe both rGBM and nGBM will be approved. I believe the MHRA conditions for timely/prompt approval are happening as we speak (aka: more modifications for process in March). If all is and does go well, I think we have some chances before 150 days (+ 60 if necessary), to be approved. Maybe quite a bit earlier, again, if all goes smoothly.
I missed it, but looking back I found it. You may want to add quote marks or a quote box or possibly inject a little bold and/or red next time. 🙂 Anyway, a belated thanks is due to you.
That portion would speed things in that we remain the “national route”, which we are, and the “recognition routes” are transferred to the recognition pathway, thus making DCVax-l in an easier/smaller to process group of applications constituting the “national route.”
Plus, the March 1 MHRA assessment modifications I previously linked, copy and pasted, will speed processing for the National route even more. See https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173931019
I don’t think you are considering the circumstances.
First, MHRA prioritizes therapies for unmet medical needs indications that are life
Threatening.
Second, NWBO applied under the MHRA’s rapid 150-day review pathway, which the agency has established for new medicines for serious unmet medical needs.
Third, the changes at MHRA go into effect March 1. NWBO will be at or near the end of 80 day phase I in March.