Have they already got P2 funding27 Feb 2024 15:39
Everyone screaming about funding, Avacta haven’t got enough money to complete Phase 2.
Remember this question:
Are you working closely with the FDA (discussions, suggestions, guidance) to get AVA6000 approved? Are you applying for Breakthrough Therapy or any other designation from the FDA? Are you applying for any designations from the MHRC or EMA?
We cannot provide further information on the regulatory strategy for AVA6000 other than what was in the presentation. To do so could jeopardise our discussions with the regulatory bodies and potentially prevents us from protecting new intellectual property. We will do so when we have concluded our discussions with the FDA and other regulatory bodies – in mid-2024.
Avacta BOD “Don’t worry about funding”
Are we all looking for the wrong funding ie: T/O, partnership or licence deal.
The funding could be through the FDA.
Eliot Forster
“And the really cool thing about our technology and there is not many companies on the planet who have this and lots are saying we want it.
Is that we hit the barricade and the actual cancer cells themselves, both at the same time and that’s a very cool thing.”
Now they are keeping their cards close to their chest on FDA discussions.
Have they had the nod on the results so far and the 2 week dosing is just a box ticking exercise for approval.
Further information on the regulatory strategy for AVA6000 will be released when we have concluded our discussions with the FDA and other regulatory bodies – in mid-2024.
Look at the size of the grants available for ODD clinical trials,application budgets are limited to $650,000 per year. Applicants may request additional funding over the above listed maximum for innovative and efficient trial approaches. The additional funding request shall not exceed an additional $250,000 total costs per year (to a maximum total award cost of $900,000 per year) for up to four years.
Of the estimated fiscal year funding for clinical trial grants (approximately $15 million), approximately $10 million will fund noncompeting continuation (e.g., ongoing) awards, and approximately $5 million will fund new awards, subject to availability of funds.
Application budgets are limited to $650,000 per year in total costs (direct and indirect costs) for up to a maximum of four years of support. Detailed budgets for each requested year need to reflect the actual needs of the proposed project including both direct and indirect costs.
Applicants may request additional funding over the above listed maximum for innovative and efficient trial approaches. The additional funding request shall not exceed an additional $250,000 total costs per year (to a maximum total award cost of $900,000 per year) for up to four years.
https://www.fda.gov/industry/faqs-orphan-products-grant-applicants
Some small bio receive ODD then sell on to BP who exploit these grants.
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