Back in 2022 many felt confident that we were headed toward an International approval with all four regulators acting together. I do believe that once we have all four regulators approved a share price of $20 or more will happen. If we get a tumor agnostic label it will be much higher than that.
I believe that $2 is a very conservative figure, but one that will make most of us quite profitable. Why? Because since 2022 with the share price languishing, we've added many more shares. I certainly didn't want this to happen, but in the long run, I believe I, and many others, will profit from the delays, and the weakness in the share price.
If the EDEN has caused the delay, or even if not, but it's approved shortly thereafter, I believe we'll rapidly learn of other regulatory filings and while additional approvals may not be till 2026, I believe there anticipation will move the stock to the $5 to $10 range, or perhaps higher if other positive news comes in.
I certainly don't know, but suspect that there are other countries which may piggyback on UK approval, especially if the EDEN approval accompanies it giving the company the ability to deliver vaccine in far greater volume than based on manual production alone. Canada is perhaps the only one involved in the trial, but I won't say Europe may not come along as well, when all this started, a UK approval would have been a European approval as it was before Brexit. Other countries closely associated with Britain, like Australia, might also grant approval as well.
As for our FDA, at this point I believe it's hard to say how our FDA will act under Kennedy. It could be more dynamic, and rapidly process BLA's and NDA's, but with diminished staffs, it could take longer to do anything as the G-D's within it want to do everything as they've previously done them and with less staff, it will take substantially longer. I've long been critical of the FDA and believe they could be far more dynamic, but I don't know that Kennedy will bring that out of them. Approving something that's been approved elsewhere and appears to be working well is easier than being first to approve, so perhaps it will be done prior to the PDUFA date they set.
Gary
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