https://www.iovance.com/clinical-pipeline/ study the pipeline and then form your opinion
there is more in the IMMU world than GBM trials. Applause yes you made it clear that you have read that NWBO conducted the only successful GBM trial but thats not the point that was made.
NWBO market cap will not be higher just because it has a successful trial for GBM
I also NWBO believe does not want to give a timeline because they depend on third parties for the completion of the application such as the clinical trial sites, the CRO, the third-party consultants and of course MHRA itself.
The BS excuse of the self-invented "Post-COVID difficulties" NWBO provided is however incredibly lame and has a white beard. A more up-to-date believable excuse would have been staff shortages.
That depends if the MHRA is asking for information/asking questions they could not have known before and which they had/have to go back to the trial sites for to get it (which I think happened here given the rolling review) then I disagree.
If its information that its more or less standard belongs in the MHRA application then it would be incredibly amateurish if they had to go back to the trial sites to get that data.
Either way, the "post-Covid" delay excuse which they are now trying is incredibly lame and I agree with you that NWBO is the slowest turtle in the snail classroom.
Btw if each RA especially the FDA has its own specific request for information they have to go to the trial sites for then we are in for a very long wait after MHRA...
well they did say this
A fun fact is that Les told my friend that they only would PR the ACCEPTANCE of the (rolling) application submission. The reason is that the if they would PR they have now submitted 100% of the application and then get rejected for some small details or unclear information they would have to PR that again. Also, they did not PR the submission of PIP but only the acceptance of it.
From the last 10Q in my view, they made it pretty clear where they are in the application.
1. "The Company is working with teams of specialized consultants on pre-requisites for the application." And what are those pre-requisites for the application then? well
2. "The clinical trial site backlogs involve delays for various clinical trial follow-up matters, such as queries and additional documentation".
A. So the company here stipulates what the "pre-requisites" are for the application. Being "clinical trial follow-up, such as queries and additional documentation"
B. How I see it they could never have known what queries and additional documentation they need for the application if they had not been provided this request by the RA (MHRA) via a rolling review.
C. Also they clearly are saying they are delayed providing this information to the RA because of "Post-COVID difficulties continue to impact the Company’s programs and operations" (Which personally I find a huge BS excuse)
3. Then NWBO gives a timeline for when they expect these backlogs to be solved and thus when they can provide the RA MHRA) with the requested info
"The Company is hopeful that the various backlog circumstances will improve in 2023."
this did not age well either
you do hopefully understand that when I said DCVAXL will be sold online as a webshop product I was joking? The perhaps was a clue?
nope they will be acquired (thank goodness). You asked for the why. I have posted about the why here many times.
Not only that but the idea that only 20 sales peoples need to be installed and the sales is a done deal is a naif dumb remark made by Powers. If you start from scratch without any contacts, years and years will be needed to present your new high-end medical product to hospital committees and MDs with a staff of hundreds not only in sales but also support.
Novocures employs a staff of 1250 people! NWBO 16
why dont you quote the rest of the Freedom of Information Act being the decision
Given the decision of the committee your conclusion "Looks like somebody is planning another derivative suit saying that LP is spending NWBO cash on Advent." Is BS
What you are discounting from the equation is that Linda chose to build her own personal CDMO first. They could have continued with Cognate CRL as their certified CDMO and conclude the timeframe for approval within 1 year after datalock but Linda decided that Toucan needed to have its own CDMO paid by NWBO shareholders .
What’s done is done and here we are now with Toucans Advent as NWBOs MIA