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"The clinical data emerging for our lead pre|CISIONTM drug, AVA6000, is ground-breaking. We are seeing a dramatic reduction in the usual toxicities associated with anthracycline chemotherapy and we have clear indications that doxorubicin is being released in active form in the tumour microenvironment.
Unbelievable but it's 100% happening
Really great find.
Based on the snippets of data released I do think further FDA support is a given however, based on historic data, Avacta has an 87% likelihood of receiving Fast track. Breakthrough, accelerated approval or priority review.
So what's the value OF AVA6K when one of these doors is opened by the FDA????
There is HUGE value to big pharma
CJ,
Phase 2 is planned to be a registrational study.
Fyi, Registrational Study means a human clinical trial that is intended (as of the time the clinical trial is initiated) to obtain sufficient data and results to support the filing of an application for Drug Approval of a compound or product.
Following phase 2 completion/approval, Avacta could outsource the production to 3rd party or simply and immediately licence the tech to each Dox player.
I doubt that these options will be reality as buy out will occur prior phase 2 start.
The ability to sell off the Dx wing is an important lever for any ongoing funding negotiations.
We are not desperate and there are avenues enabling avacta to fund AVA6k all the way to final approval / revenue.