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Patience
https://youtu.be/CU1cnFt5KSo
Surely phase 1a results will land next week?
Undone my buckle now Sujood…. Should I strap in again on Monday?
Haaaaaaaaaaaaa that’s so funny!!!!!!!
MrA, can you explain your reasoning? You don’t think there will be US hospitals involved until mid-Phase 2? Or is this a typo and you meant Dec 2022?
Also help with NASDAQ fund raise
This is why we need USA trials. Avacta could get to market a lot quicker with FDA on board.
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
if ongoing AVA6000 trial data results looking good might not need 4 cohorts .
Maybe 4 or 5 sites in UK is all that is rquired now to complete phase1a. No need to increase dose just stick with 160mg/m2. .
announced " Wed, 29th Jun 2022 07:00" --- assuming enough patients have been recuited across 3/4 cohorts & cancer types etc .
"Avacta's Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has completed its review of the safety data from the second cohort dosed with AVA6000 at 120mg/m2 in the ongoing Phase I trial. Following this review, the SDMC has recommended that the clinical trial continues as planned and escalates to the next dose of AVA6000 at 160mg/m2. "
Sujood is actually Al Smith messing with us.
Be interesting if he's actually right ref US Sites in Aug. . .how could he know?
Only thing US brings is a bit more "Provenance" but... dont think its needed or will make any impact on the SP.
Given the low number of patients required for P1a I'm of the view they should stick to UK sites now to ensure the continuity risk is managed ie it's same teams at the same hospitals doing the same trial steps they have been doing for a year in some cases.
If we also consider the biopsies AS stated they had a world leading lab here in the UK ready to analyse these. It makes sense to do them all in one place for this low number of patients. UK sites removes any possible issues of international transport and expedites timeframes. We don't want biopsies assuming they can be frozen and transported going AWOL and end up at the baggage dump at Heathrow so why take the risk.
I'm sure US sites will be very useful when we have 40-60+ patients to dose in P1b.
Got to 1b now. They’ve held Q3 twice. Any US news re DE, I’ll be assuming slippage.
Not even sure why they reigned so bullish on US at this stage. I don’t see it as adding much benefit other than a bit of kudos?
The y contribute to dose escalation phase, as per business update
US IND approved by FDA in November2021:
•Two US clinical trial sites being initiated and should contribute to the dose escalation phase.
Does say "should" though, and it seems they would be a bit late for that now
PA00H - it is one trial.
Tbh I’d rather not hear that a US site is coming online until phase 1b at this point, as it could mean resetting the timeline on the current cohort.
We are 40 days into the third cohort of phase 1a. Each cohort only takes 3 patients, if all goes to plan.
Very early.
Sound logic hank
But now your older I assume your a laugh a minute :)
When I was 5 years old I thought that the more times I repeated a joke the funnier it got ....
Coffee shop on the corner of Wall St is opening early tomorrow
BEGO on the bid already, they know what's coming in NY coffee bean futures....
You're a breath of fresh air Sujood - never explain, never complain.
12 recs...wow
Well done to all who recommended sujood's post
@livedata could be!! What dyou mean ? It will be, sujood is always bang on the money, almost.