Far out I should be working and leaving this alone but people such as you get under my craw. Look you want facts and figures. There are plenty and plenty of them. But in the interim please don’t move the goalposts, as you are. I’m beginning to feel as if I’m in a Jordan Peterson interview. You started off saying you thought Azer Cel could achieve approval in 2027 and Vaxinia some time after that, assuming say 2028. Now you are suggesting late 2027. So let’s take the median and work on early 2028 for your opinion shall we.
I am, once again and for the last time, saying FDA approval Vaxinia is not got to take that long. Purely IMO…
Fact 1. Almost half of recent new drug approvals in recent years were based on only one pivotal clinical trial instead of the two or more that used to be the norm, according to a study published in 2021 by JAMA, the journal of the American Medical Association. And the reliance on surrogate measures — stand-ins for presumed patient benefits — has increased. In the case of cancer drugs, a surrogate measure could be shrinkage of tumors instead of improvements in survival after treatment. See https://www.npr.org/
Fact 2. Gastrointestinal tumours aren’t your common garden variety unmet need. They are up the top of the tree when it comes to "we need to find a cure, and fast." There are little or no treatment options currently available to late stage patients. I can remember way back in the early 2000’s (I forget whether it was CFS or the BT biotech, or International Investment Funds), one of them had Novartis as a holding. Their drug imatinib was approved at the time via the FDA Fast track Approval Process and Priority Review in two and half years. Guess why? It was treating among other things, gastrointestinal tumour’s.
Fact 3. If they have performed trials with patients comparable to the size of the Vaxinia Trial, drugs with outstanding results such as Enhertu, treating much more common cancer indications such as breast cancer where there were already successful treatments in place i.e., Herceptin, are being granted approval via the FDA Priority Review designation in rapid time.
Vaxinia is going to have patients queueing up for whatever trial the FDA throws at it. But if the JAMA study is anything to go by, there won’t be many more than the expanded (then probably expanded again) Vaxinia (MAST) Trial required. That is before we see the FDA recognising the drug has achieved the necessary intermediate or surrogate endpoints required (IMO).
I note LC’s team is having difficulty fielding all the emails from patients wishing to participate as it is. Enrolment for an extended period of 18 months isn’t in the equation here.
Best not be too long winded though. Goodbye
Please keep DYOR, as clearly your not taking mine into account…These are my opinions only
(20min delay)