Hi @Mason14, @unbelievable & All,
Wow! Poor @unbelievable, I hope you didn’t have any kind of life planned this weekend with all these questions requiring a direct answer lol. Anyways I thought I would help out a bit & start at the top of the question list.
HER-VAXX PH1B
I think all of your answers are there in the paper (link below) Mason, & the protocol, you need to read all of it properly with all due respect.
The question regarding discrepant data in the abstract vs the table: The data evaluable at Day 56. There is no discrepancy.
The question regarding primary endpoints.
Primary Endpoints for Ph1 are clearly listed in the paper & Clinical Trials Registry (links below) & there were also other multiple exploratory outcomes including clinical response (ie “best response”) see links. That is where that comes from & is discussed in the paper.
The question regarding chemotherapy: So in the study design, this describes the protocol for the administration of chemotherapy, including treatment timing & doses.
In a clinical trial, it is possible that patients may need to have doses lowered or delayed, due to toxicity, or other AEs, SAEs, but you cannot administer a drug on trial that goes over that maximum dose, or change drugs to ones that are not part of the protocol, that is a major protocol deviation. So that is why that statement is there.
The question about grants:
Grants are very common for Investigators/Researchers while on trial & there has to be complete transperancy in regards to these & there are strict rules about grants from Sponsors & what they are being given for.
That is why there are always Disclosure statements on published literature & any presentation during conferences including oral. Grants may include things such as travel costs to present at conferences & assistance with research costs.
Everything has to be documented & records kept. There is nothing “fishy” about that. Pharma companies are not even allowed to hand out free pens anymore, & that truly sucks, because I see them as a vital clinical tool you can’t live without everyday! Anything they hand out must be of benefit clinically to patients & pens apparently aren’t. You can look up the legislation if you like.
Links in reference to above:
https://clincancerres.aacrjournals.org/content/early/2021/05/06/1078-0432.CCR-20-3742.full-text.pdf
https://clinicaltrials.gov/ct2/show/NCT02795988?term=Imugene&draw=2&rank=1
I hope that helps answer one of your many questions Mason. Thanks for your links also, will take a look.
Also I just want to say, there is a bit of banter here about RAC vs IMU. I don’t want a part of that & both companies are seeing success & a common goal for the greater good in Cancer treatment. Neither company deserves to be muddied by HC posters. If there are respectful questions they deserve to be answered & we should expect them with all the buzz around IMU’s pipeline at the moment in what I believe will be a Paradigm shift in Immuno-Oncology.
But remember there is a lot of space for different therapies in the Oncology space - Collaborations & Combination therapy is a key driver & we are seeing that more & more now.
Have a lovely weekend all & will try to assist with more questions if I get the time today.
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