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What is so complicated?
Nothing has changed with the status of Reveimmune Inc, the company that has the Il-7 product being discussed.
As far as Revimmune Limited (as I assume that is what you are looking at), I would guess it is some UK paper company owned by the US company. I could care less what changed with it, if anything.
This is a frigged stupid as when DD and friends were asserting some huge event had happened with NWBO Limited for the same reason.
Yes, as she always has been.
The assertions by DD, ILT and dstock that something changed with them and NWBO Limited is nothing more than there usual nonsense. They posted documents that never said anything at all about such a change.
If you disagree, how about just showing any actual source docs that say some status change happened.
LP (via Toucan) has owned Revimmune for years and you know that.
The documents DD and his cast of clowns never said anything about LP changing the status in any way.
That is just a reply by somebody to the SEC spouting all the fantasy crap about "counterfeit shares".
Even if you believe these billions of fake NWBO shares exist, a new CUSPID does nothing.
Clearly not DC-L as they were pulsing DC with KLH in addition to various cytokines.
BTW, that trial completed 12 years ago.
Nobody knows. According to the 10K the contract for commercial production has not been agreed upon. So LP can negotiate what she wants
I so love all this Revimmune hype. Anybody wonder how good a deal LP with negotiate with herself?
Do have to give Rev some credit though, they actually ran a randomized trial for their IL-7 and reported the results properly.
NW Limited (by either name) is no more than a totally owned subsidiary of NWMO set up years ago to handle the real estate transaction.
Nothing recently has changed, and none of this maters at all.
Definitely the mechanics.
The electronics for this are nothing. a control system with a few dozen inputs and a small number of outputs plus coms.. Once you have a concrete design there are thousands of companies that will build tested circuit boards for you at a modest cost. If they were cost sensitive they could probably get the COGS for a tested board under $100.
Oh, and nobody would build this with either "programmable microchips" or a PLA. It would be a vanilla setup with an Arm SOC and eMMC. The crap one poster here has been talking about has been obsolete in this space for 2 decades.
For disposables, the only issue is the one time setup cost. That may not be chump change.
So you think they were secretly approved for EAMS by the MHRA?
Reality is NWBO received the PIMS designation (step 1) and no hint of having been actually a positive EAMS decision from MHRA.
The accepted PIP calls for a completion date of summer 2028.
The EMA rules (that MHRA is likely still following) allow for deferrals of both completion and initiation. I would be virtually certain NWBO has no need to complete the PIP studies prior to MAA approval.
As far as initiation, I would think that depends on the details within the plan.
I did see someplace (forget where and would need to dig it up) that the RA (forget if EMA or MHRA) checks up at 2 years to insure the plan is on track. If so, that could be why LP mentions the trials have to start this year (the pan was approved Aug 2022).
In general though, I think the PIP program is more of a gentle pressure than a hard whip. It would be insane to keep useful drugs off the market for years.
Sad for you then that DCVax-L never received the EAMS interim approval that the PIMS designation is designed to lead to.
I would guess every EAMS drug was subsequently approved (or waiting approval).
So now just using radiology is a conflict of interest.
Sure, they really are all out to get you.
I was presenting number of shares, you have dollars. Also, sold and converted are not the same.
That trial was PRd as supposed to start 8 years ago. Nothing happened.
What next? Are you going to hype the prostate P3 that was announced 23 years ago?
I do have to laugh about longs calling you a basher for not being reasonably certain of approval within 150 days.
Anyway, on the core subject, I doubt any novel agent has received an EU/UK approval w/o an RFI and clock stop. In EU the first clock stop is now mandatory.
And the complexity of -L would be off the scale. Consider 2 sources of issues to be ironed out.
1) What is the rGBM label? The trial used -L immediately after progression. But that required -L to have been already manufactured subsequent to nGBM. But if manufactured then, would it not have been used then? How exactly would one write this label?
2) Manufacturing. As a rule, biolologics are approved using the manufacturing as established in the P3 trial(s). But these long since have ceased to exist, They now have a new mfg facility. That the facility is approved does not mean that it has been established to follow the same process to manufacture -L. Yes, they have put together a plan to establish this, but such are often bones of contention.
And these to not even take into account the elephant in the china shop issues of the trial and switch to ECAs.