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dennisdave

07/07/22 6:33 AM

#492944 RE: pqr #492909

Thank you PQR,

I dont have PM :)
What I think has happened is that Northwest (their lawyers) felt compelled to contradict the hardened rumors on message boards and social media about a fast upcoming MHRA approval and the many times they have been asked about the MHRA pending approval. Not to say the least because it was LG himself who in Oct 2020 in the Big Booz show claimed that MHRA approval is imment.

So although I do think that Northwest has prepared the submission of the request for approval, I don't think they have submitted anything yet. I think they are waiting for approval of the manufacturing license for commercial production of cellular products in the Sawston facility by year-end and THEN submit a request for the approval for DCVAX L. This is for the simple reason that Northwest wants to make sure an approval will not be declined based on the pending capacity of production of DCVAX-L. This will thus take us to Q1 2023 for MHRA approval of DCVAXL just like SOS predicted.

If we are not going to be diluted like cheap soup then I expect the SP to rise in anticipation of MHRA approval over the course of the next 9 months to $5-6$
IMO :)

antihama

07/07/22 8:53 AM

#492982 RE: pqr #492909

Pqr, true that Sotorasib is not a biologic but TLD is TLD (they are both apples) and once you have it the clock starts ticking. The Criteria for BTD is - a drug that treats a Serious condition, AND Preliminary clinical evidence that indicates that the drug may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints. Besides seeing this evidence on May 10th, you know they have every nook and cranny of the data analyzed. I mean they had since Nov 2020 to figure that out. And presumably the journal article will have all that too. Is it too much to expect NWBO to come through w this expectation? Maybe but hope not.