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Tuesday, October 03, 2017 6:25:05 PM
Remember the Ovarian trial? That was the one I argued was when the IND was switched for DCVax-Brain to DCVax-L because the timing was oh-so-perfect prior to the 2011 start back up again of the DCVax-L trial. You'll recall it was a P1 trial and they tested it for safety.
https://clinicaltrials.gov/ct2/show/NCT00603460?cond=DCVax-L&rank=1
Anyway, I found it odd that some changes were made to that trial in April 2017.
They removed Carl H. June, M.D. as the responsible party and changed it to simply be "sponsor" - which was Penn.
Now it's interesting to note Carl June was instrumental in the work behind CAR-T. Maybe he doesn't want his name to be affiliated with DCVax-L in any way?
https://am.asco.org/dr-carl-h-june-highlights-promise-car-t-cells-karnofsky-lecture
http://www.cell.com/cell/fulltext/S0092-8674(17)30064-8
Next, they changed the regulatory authority from
United States: Food and Drug Administration
to
fda_regulated_drug
fda_regulated_device
product_exported_from_us
Now there's likely some sort of reason to change that listing to the new one. I'd just be curious what it was.
There are a couple of other nominal changes that really aren't even worth mentioning.
But one I did think was worth bringing up was that they also changed the last release date from August 15, 2016 to April 28, 2017.
I was wondering why.
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