Wednesday, April 22, 2020 11:18:14 PM
Going forward, LG is pretty confident that TLD will be announced in early July. Data lock should happen on or about end of May and then the external parties do the calculations on the unblinded data which should take a couple of weeks and then NWBO and its experts will look at this out put and prepare for presentation. That should take about three weeks. So we are in the first week of July or thereabouts.
LG said that the UK RA, I believe it is the NHRA, is ready to accelerate approvals, depending of upon results of the trial. The approval process usually takes about 13-14 months, however, NWBO is one of only three companies that have been approved for accelerated treatment and that should take about 3-4 months. It is a very good bet that NWBO could get approvals from the UK comfortably within this year. The EU countries plus Canada should follow closely thereafter. The foregoing is according to LG from a recent conversation.
The FDA will have no choice but to approve reasonably shortly thereafter. There are a number of reasons to which I am privy but will not share on this MB.
it all comes down to the results. If good, approvals follow relatively quickly. The results are expected to be remarkable. Yes, they are looking at a number of markers, i.e., methylation status, IDH, etc., however, LG said that remarkably the vaccine works across the spectrum and he is privy to a lot more info than we are. Note that Dr. Ashkans said exactly the same thing and that the vaccine should be made available to all.
LG and the NWBO management team have been maligned and their reputation impugned. LG knows this. As far as I am concerned, I believe that this ASM did much to rebuild their credibility. Although I was disappointed about not having TLD, I think they otherwise did an excellent job at the ASM--- credible, reasonable and confident. LG was true to his word. A PR was released contemporaneously with the start of the ASM. There is definitely light at the end of this long tunnel. There is a solid basis for hope that indeed 2020 may be NWBO's year.
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