“The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax®-L.”
“The Company submitted its proposed PIP to the MHRA in February 2022, and has been going through the regulatory review process since then. On August 17, the Company received final approval of the PIP from the MHRA.”
1/ "Only 5% of glio patients survive for five years. So how stunning is it for DCVAX-L to see life expectancy at 60 months rise from 5.7% to 13%, an increase of 228%. Some patients have seen total remission glio and are cancer free more than a decade after treatment.
2/ For example, Brad Silver participated in the Phase 1 trial 17 years ago and is cancer free now."
If you watch this by idea closely, you’ll note that the trial coins not proceed ethically UNLESS it was a crossover style. But all the patients lived longer including the recurrent ones who got access to #DCVaxL late. THAT was their placebo arm originally. There is no way in hell
, in my opinion, that a regulator is going to push a drug company into a crossover trial ethically, and then say, oh, man, your drug is so successful in making everyone live longer, but there is nothing that can be done. You fail! That’s not how regulation works.
“We caught up with management ahead of several catalysts expected in 1H21.
3/ In our view, recent share price weakness has mostly stemmed from lack of near-term catalysts. However, investors accumulating now are likely to benefit from positive news flow through mid-2021, leading to a rerating of shares.
These reports seem a bit backwards. The banks are not police agencies. They are reporting these transactions SO THAT if it is illegal, which might be the case, the govt investigates.
They are saying, hey, we do not know for sure, we are not spies on our customers and are not police, but you should look into this and tell us to stop, if it is actually illegal.
Apparently they file and FinCen never does anything. It’s also possible FinCen wants to spy.
If that is the case, then the reports allow FinCen to follow money trails and figure out who is involved. Banks stopping it actually shuts down the info flow.
The question is, does the government then ever actually do anything about these reports? That is a subtler question.