Personally the fact they’re not appearing to be at ASCO is compelling. They’ve used ASCO in the past and that always ended up disappointing share holders. They’re not going to unveil TLD at a Virtual Conference that no one will be watching in great numbers. That to me is a better signal than actually presenting there.
However, I think they’re simply continuing to work through the data, putting together the appropriate ways to present the data to the Regulators in a BLA, and working on Peer Review. We’ve seen this past year how long everything took because of COVID and the need for outside expert consultants; a combination rife with delays. Scientists who’s lives revolve around science and getting it right are there precisely because of this and are not going to be worried about us shareholder’s interests or excitements. I work partially in Academia and I assure you there is a certain purity in the majority of Scientist’s intentions outside of those with their own particular favoritisms. And if you think herding cats is difficult herding scientists is it’s own special hell. I believe those in the SAB and other consultants have to come to a very precise consensus on what’s coming and I believe what they’ve seen of the data has more than likely excited them greatly. But there are also Lawyers involved, adding another level of detail in dealing with both the FDA and the SEC regulations. This is a big production and I also believe the richness of the data has made this a much more laborious project than any of us could have imagined.
I believe the length of time has created opportunity for all kinds of wild speculation, I’ve done it myself. But I believe completely the time delay is almost entirely about those who’ve been unblinded understanding how great the data actually is and how careful they must be because there is so much more at stake here than shareholder’s profit. This is going to be truly translational, and I believe quite shattering to the scientific community. With that they absolutely must anticipate each and every shot that will come their way by those who guffaw at science outside their own staunch conservatisms or prejudices. The balls it’s taking to go with Historic Controls here is not something most on this board comprehend. The scientific community is in a transition that comes around only every so often because of the COVID crisis; from treatment to the incredible vaccines look no further than to the MHRA (first to grant emergency authority to Pfizer) and now Canada’s HPFB (first to authorize Pfizer for 12-15 year olds) to see how change is occurring. I believe, as I have now for months, that the MHRA, the EMA, and the HPFB are prepared to grant authorization to DCVax. I don’t think there’s even a slight doubt. And I believe the FDA is on board also, the guidance from 2018 was an obvious nod to DCVax. Buyouts? I have no clue, it’s not my thing. But I can read the tea leaves that are laid bare and those leaves point to something about to break wide open and change the very face of how Biologics are trialed and approved. Remember...DCVax is the safest Cancer treatment we’ve ever seen outside of a device. Ever. Let that sink in good and long. This is happening.
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