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A G Bell ok
Muck165 totally agree that this seems to be exactly why the company is going down this route.
As cohort 6 took from April to Sept with 3 weekly dosing and the parallel study using AVA6000 for STS will be using a two weekly cycle the study will most likely conclude within Q4.
If this study provides results that show tumour shrinkage and/or other clear clinical benefits (tolerability & decrease in negative side effects) then this is exactly what is described as being required for Accelerated Approval to be granted by the FDA see Project Confirm -
Q: Are specific endpoints used to support accelerated approval in oncology? Are these different from the endpoints used to support traditional approvals?
A: In oncology, accelerated approval has frequently relied on the endpoint known as overall response rate (ORR), which is a measure of whether tumors shrink or are eradicated after treatment.
https://www.fda.gov/about-fda/oncology-center-excellence/project-confirm
Yes I could see them not being able to scale up production fast enough given that each patient would be on much higher doses and more frequent cycles with an unknown extended lifetime cumulative amounts.
This is probably why one of the big pharmacy company’s who currently produce doxorubicin would offer to step in and make an partnership offer but given the number of company’s currently producing doxorubicin Avacta would be in a very strong negotiating position. They could simply licence to each company ££££ and go on to develop AVA3996 and other drugs.
The patent in the US is secure under the filing for IND for at least seven years. I’m not sure about other markets
“Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy”. 🤔 seems like a ✔️ to me!
For those that want it here is the link to the FDA site;-
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
Fast track approval is a process designed to get important new drugs to patients earlier. A request can be made at any time during development by the drug company and a decision will be made within sixty days based on whether the drug fills an unmet need in a serious condition.
SYOR but I’m confident.
Are you reading my emails Timster? 😂
I’m very happy to have the majority of my shareholding in Avacta. The pivot point for me was re-reading the FDA guidance on the process of fast track approval after the announcement of the forthcoming trial of using a two weekly dosage for STS.
Just added another 2330 shares GLA
Should AVA6000 be approved for treatment of soft tissue sarcoma, (which seems to be the path the company is exploring with the FDA) then ODD provides seven years of market exclusivity in the US, which will be a very significant commercial pivot point for the company. Much more significant will be the general proof of commercial concept for the entire Pre|cision platform with a major rerate upwards for the share price on the cards! Al might not do boosts but the results themselves will. GLA
Knotagain my experience (father in law had multiple myeloma and tried doxorubicin but couldn’t handle the side effects so chose to stop chemo). So I agree wholeheartedly there will be demand from patients and we are very close to that tipping point
Thank you 😊
🤔?
RorkesDrift it could always be that part of the new doctors remit (recent hiring) is to review the data so far and publish it?
Bashers* (the FUD crew)
Always a good sign when the badgers come out!
Not sure what the significance of joint brokers is?
But positive RNS welcome aboard Dr Christina Coughlin - looking likely to expand beyond STS initially to breast and ovarian trials!
Hold on to your hats!
🎩 they might be safe today but could well get to hat eating territory tomorrow! GLA
Very good points Ceesor / also he mentioned the read-across to AVA3996 and validating the wider platform. Which makes me think he values 3996 at least as highly if not more than AVA6000!
JAdam posted he sold at £1.19 this morning.
So clear that you regret selling! 😂
This from the RNS seems an indication of fast track approval for AVA6000 to be used in STS and Dr Tap could have been key in convincing the FDA “the Company intends to begin a short study to explore more frequent dosing (fortnightly) of AVA6000 as a first line treatment in patients with soft tissue sarcoma. The study is expected to begin in Q4 2023 subject to receipt of approval of a protocol amendment from the US Food & Drug Administration (FDA)”.
It doesn’t rule out using it for other cancer types but it may be about to replace dox