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The only interesting thing I expect to see in the new complaint will be how they explain that NWBO sold stock at prices that depended on the close on future dates.
The asserted facts in question is the table starting on page 91 of the the first amended complaint,. The Court is asking for an explanation of that table.
What I expect to see is a very different table, I strongly suspect the existing table is a mix of aggregate transactions and detail records. They will need to this.
The question then is what they are left with as asserted damages., They are already almost nothing per the Court's decision when granting the MTD. They might be chump change after the redo on that chart.
Expect to see Friday night.
The FDA always releases the staff review and briefing documents a few days prior to the ADCOM meeting.
Jrroon71, a follow up question. The proposal says that it s eliminating the $1.3M in the "Share Premium Account" thus making it available for distribution. Why only $1.3M in that?
By my understanding, the SPA is what us rednecks call "Additional Paid in Capital" , and that is $1.9B. would expect a reduction in capital to reduce from that number.
Is there an English->English translation problem here or what?
What about an acknowledgement that they have been granted a 150 day review track? That (FDA Prority Review, EMA PRIME) is almost always PR'd for material drug approvals.
Clearly the $11B that Nova Nordisk is paying is to be prepared for manufacturing DCVax-L if they when the bidding war..
On Flaskworks not needing a comparability study, what can I say. Anybody knows this is needed for a major process change and NWBO says it is.
On you sig line, ATL-DC vs DC-L try this:
ATl_DC is made with one batch per dose, per the combo trial paper pre-print
Crickets are warmed up and waiting to go.
If there is basically no real buying or selling then the aprox 400k shares per day NWBO sells to stay in business weighs on the markets.
I have to credit the manipulators for keeping the PPS propped up this high for so long under these conditions.
IMO, they already did.
Unfortunately for Dr Mullholand his IPI-GLIO failed failed because the SOC arm did so well.
Well, Doc L asked me to reply. So here goes.
No update on the Court case. Expect anytime in the next week.
Flip, he already said he stopped all treatment at 6 weeks post surgery prior to receiving any DC-L.
He actually said he withdrew from the trial prior to receiving DCVax-L
You do understand that these are not pricing/payment discussions, but simply discussions about when and how the NICE process can proceed?
One would have expected to start this at least 6 months ago when NICE was calling them. But maybe NWBO knows they are in no hurry.
The real question will be where does the NICE process pick back up at.
I think there is reason for them to say another scope/matrix are needed. The previous ado not have the right indication, have incorrect statements about what is now being reviewed and is six years old.
Will they issue a new set of docs? Will those be draft or guidance? Or do they just forget that and start the meeting invite process.
Good news is that NICE is a lot more visible than RAs.
About $150k/year is list, but I guarantee you NICE is not paying nearly that much (it is already being reimbursed for HER2+ patients).
A summary of Canada's rejection of the same drug/indcation
Is there a way to get somebody to piss in the bottle for you to fake the genetic market test for HER2?