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Sunday, November 08, 2020 10:13:18 AM
1) Yes, it's now a fact that EU, specifically UK and Germany have approved our SAP which contains the adapted endpoints;
2) Maybe partly because of 1), DI expects the same from "the other countries," presumably US and Canada for buying in shortly; and
3) Since he mentioned he could not say much because the company was in the quiet period at the time, this suggests what we can wait for from the company as a result of its quiet period is not the US and Canada's buy in for adapted endpoints, but something else.
So what could that something else be? Of course, top line data could be one. Besides that, maybe the company was waiting for some kind of important regulatory decision, or maybe by that time (a couple of weeks ago), only Linda Powers and Les Goldman were unblinded who were then in negotiation with Merck representatives who were also unblinded and signed NDA for a deal, either partnership or buyout.
Maybe the partnership or buyout deal was reached after both parties had reviewed preliminary unblinded data, and now maybe pending official US' buy in.
So as of recently, even Linda Liau had been kept out of the loop, not yet be unblinded, and the withdrawal of conferences are also the result of the above.
So maybe when we have top line news we will also have the news of a deal with Merck and/or some substantial regulatory decision on our favor. We will be instantly on a rock solid base with share price in double digits reflecting the deal.
The bottom line is we pretty much have EU in the bag for approval (an anchored share price of at least $2 if the price reflects reality for EU alone), and it seems US and Canada will soon follow suit, by first buying in for adapted endpoints. In the meantime, all others may just be wild or entertaining speculations.
Lastly, I thank you all from the bottom of my heart for reading and responding to my posts. My apology for not responding to each of your posts, either because I don't know how to appropriately respond, or because I personally want to limited my exposure in ihub which has "generously granted" my wish and given three posts a day for me.
Very exciting journey ahead of us, wishing we all a good luck!
[In concept, the name of Merck can be replaced by any other big P; it's just like more likely Merck is the one coming first, maybe because Duffy's short employment with NWBO and/or reported Merck sVP's handshake with Ms Powers at ASCO. If Merck is indeed the one, it only means that it has the first right, other big P can also come into competition afterwards]
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