Are you saying Les did another appearance, I'd like a link if he did. I don't place a high regard on that show, but I understand it has a lot of listeners, so I'd rather see that than nothing.
I too believe the silence has a reason and when they come out, it will not be just one announcement for approval, they'll be rolling out news regularly. When I say MM's controlling things I'm really including those behind their actions, namely hedge funds with short positions.
I do believe the Nature article was great news, but only because it documents what investors knew was happening, but now we have it in black and white in a peer reviewed article. While I believe we should be priced dramatically higher, especially knowing we're about to get an answer from the UK that most current investors believe will be positive. Clearly many still don't believe we'll gain approval, but if we're right all their arguments will fall by the wayside.
I believe they went with the UK because the UK not only has the most experience with DCVax-L in brain cancer, they also have the most experience in other cancers through their compassion use program. I think they're likely to permit its use in many forms of cancer, and pay for it in their system for their citizens.
I wish I was certain the FDA will be among the next to be applied to, but I still believe that's dependent on the EDEN for commercial production. Barring some exception to their rules, I understand that biologically based products must be made in the US. If that's correct, even if Sawston has the capacity, they can't deliver to the US. I don't believe the same applies to Europe and Canada.
I do know a number of credible posters who don't believe DCVax-L can gain approval, but not because it's not effective, rather because they don't believe the regulators demands were really satisfied in all the changes made in the trial. If this were 20 years ago, I'd agree with them. I believe the regulators have become more flexible, not on what they demand, but on permitting change underway to meet their demands, which also can change while a trial is underway. I believe many future trials will be designed without control groups, the trial outcome will be compared with historical data. We've seen a Journal from the FDA stating this, but not finalized guidance from them on this issue that I'm aware of.
I frankly don't know how the next trial, or trials, for DCVax-L will be structured. If you're going for a tumor agnostic label, can you tackle multiple solid cancers in one large trial, or do you need multiple smaller trials, each for a different form of cancer. In the early DCVax-Direct trial they went after a variety of cancers, I just don't know if they could have expanded that to a pivotal trial, or if the regulators would have wanted trials by cancer type.
I'd agree with you that most investing in biotech's know about the disclaimers in commercials on drugs, I don't think that the viewing public is nearly as well informed. I'd like to know if those of you in Europe, etc. find the same sort of disclaimers in countries outside the US. I believe the regulators go way too far in trying to protect us, rather than trying to benefit us. How many people might have benefitted if the regulators issued EUA's for DCVax-L in the mid 2010's when they agreed to the trial changes during the halt.
Gary
Bullish
