BK, do you believe its possible that the new protocol for injection site redness is what allowed for this dose increase? We know Harvard is slow and safety board is tight. Are we shooting for Kevetrin at 500 now!!! Might explain infusion rate protocol change?
Looking from the outside and if this wasn't being done in humans this 350 dose appears to be seeking some DLTs. Feels like they are trying to wrap things up OR we have a ways to go still perhaps their is more beyond that original estimated therapeutic range?
The big jump to 350 mg/m2 is somewhat surprising. I was expecting around 280 mg/m2. I agree that the big jump does not mean DF wants to end the trial quickly at the risk of patient safety. The 67% increase tells me that 1 out of 3 patients received a Grade 2 AE in cohort 8.
Looks like DF is still in control of the information flow. Just like before, Leo can only disclose cohort # and dosage in the PR. It appears that the Aruda dispute has nothing to do with it.
The good news is that DF has sped things up. The safety meeting took place only one week after the completion of cohort 8, and the dosing of cohort 9 is starting this week.
It's extraordinary and seems much more significant than share price suggests. I would have guess they'd go to 275 or so. But they must already see what they expected. The problem is cohort 9 means many more months to go. But gosh, what a jump. And as you say, safety first, then it's a good guess this is the last cohort.
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