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https://avacta.com/ava6000-receives-orphan-drug-designation-from-the-us-food-and-drug-administration/
The FDA granted Orphan Drug Designation (ODD) to the pre|CISION drug candidate, AVA6000, in September 2022.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
âFast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical needâ
âSerious is based on the impact on survival. Heart failure and cancer are obvious examples of serious conditionsâ
âIf there are existing therapies, a fast track drug must show superior effectiveness, avoiding serious side effects of an available therapy, decreasing clinical significant toxicity of an available treatment"
âFast Track designation must be requested by the drug company. FDA will review the request and make a decision within sixty daysâ
AVA6000 ticks a lot of boxes.
- Has Avacta already requested âFast Trackâ for AVA6000?
- Is the RNS pending with others (Next Cohort, Phase 1B, Parnerships, etc)?
There is so much going on and so many different updates that could land at any time.
Hold & GLA
Worth a repost. Thank you Wiggly
1. Does AVA6K circulate in human as an inert agent?
Yes, this is now proven via significantly reduced side effects, 4 x DE (up to 200mg!) and plans for DE5 and DE6.
2. Is the pre|CISION chemistry cleaved by FAPa?
Yes, 6 x Biopsy data confirm this.
3. Does the pre|CISION chemistry deliver therapeutic doses to the TME?
According to CEO AS it does! See above, 6 x biopsy (100% hit rate). Would he say this and present something different at the science day!?! Of course not!!
4. Does Doxurubin kill cancer cells?
Yes, it is the most potent Chemo there is.
5. Is the data from Phase 1a unequivocal?
Yes, according to AS it is. Would he really state that data was unequivocal only to present data at science day, backed by KOL, that was not unequivocal?
If the answer to each question here is yes, then in my view, Phase1a is/was pivotal !!!
I'd welcome any counter.
I have been here for a while and I do appreciate the contributions from several regular posters. I now have a green list (filters) that exceeds 50+ accounts. I do not read their content and I do not engage with their posts.
It has been said many times before. Bin the nonsense and letâs focus on the very positive future for cancer treatment(s) and the many other offerings that Avacta has to bring.
Not long now.
GLA
Good Summary Wiggly
We (Avacta & shareholders) have a scientific development (AVA6000) that has the potential to change and revolutionise cancer treatments and save many lives.
AVA6000 is part of the game changing product offerings from Avacta.
There are several individuals who post on this string and bring well researched content, thank you.
We are now at a MAJOR phase in cancer treatment(s) and the evolution of Avacta as a medical and scientific company. There are many significant partnerships and revemye streams to follow.
Not much else to say. Letâs keep the content focused and on stream.
Anticipate additional RNS(s) before the Science Day.
GLA
The good news is, it works!
We have âa marked reduction in the incidence and severity of the typical toxicitiesâ
Also, âDoxorubicin is being released within the tumour tissueâ
âWe work towards realising our vision of "chemotherapy without side effects"â
"We are now in a position to proceed beyond the fourth cohort in the dose escalation study to even
higher doses than originally anticipated, which is an unexpected and very positive developmentâ
- Dox is in the tumour but, how much?
- Do we require further cohorts to achieve the same level as the current treatments
or have we already exceeding these?
- Are we continuing to push the boundaries to achieve MTD?
GLA
BuenaVista posted a list of 100 Top, Publicly Traded, Big Pharmaâs at 13:34 yesterday, (thank you).
https://companiesmarketcap.com/pharmaceuticals/largest-pharmaceutical-companies-by-market-cap/
I am familiar with around 20% of the companies.
Key Data:
- Market Capâs range from ÂŁ 3.6bn to ÂŁ 471bn.
- Revenue from ÂŁ 870m to ÂŁ 315bn.
- Earnings from ÂŁ 100m to ÂŁ 35bn
I have been invested in Avacta since 2013, (10 years). I have done my research, attended trade events and read bulletin boards such as LSE. I know more about Avacta, their products and management than I know about any of the 100 top pharmaâs.
There will be many institutional and private investors who will be the opposite of me. They will know all about Pfizer, Roche, and Glaxo and will already be invested. They will not know Avacta.
The RNS(s) updates in January will grab the attention of both Big Pharma and Institutional Investors. Many will be looking to learn more and invest.
The Science Day in February is the opportunity for Big Pharma and Institutional Investors to learn more and either partner or invest in Avacta.
The World is about to be introduced Avacta.
GLA
It does not matter who you are, what you do, what you have achieved or how much money you have in the bank. When cancer comes calling, most other things become insignificant.
Today we learn about the death of Gianluca Vialli aged 58. We lost Steve Jobs at 56 and Linda McCartney at 57. Cancer is a horrible disease and we wonder how many could have been saved with treatments such as pre|CISION?
News will be with us soon and hopefully pre|CISION will transform future cancer treatments and outcomes.
"Provide this personalised type of treatment to about 10,000 patients by 2030 "
https://www.bbc.co.uk/news/health-64176038
10,000 patients over the next 7 years.
How many patients will be treated with pre|CISION products over the same time period?
Monday 2nd January was a holiday in the UK and many will have taken additional leave until Monday 9th January 2023. The expected updates (RNS) are too big and too important to release when the market and media may not be at full capacity.
Expecting that the anticipated news will be released around Wednesday 11th or Thursday 12th January which still leaves 7 weeks until the Science Day on Wednesday 23rd February 2023, (https://avacta.com/avacta-to-host-therapeutics-division-science-day-on-23rd-february-2023/)
Having come this far, sit tight, the big news will be here soon.
GLA
(Originally posted 29th December 2022)
Hello Bella,
People should not panic if the news (RNS) does not arrive the first week in January. Week beginning 9thJanuary makes sense, however, as long as the expected BIG NEWS arrives during January, I donât mind which day, :-)
GLA
Monday 2nd is a holiday in the UK and many will have taken additional leave until Monday 9th January 2023.
The expected updates (RNS) are too big and too important to release when the market and media may not be at full capacity.
Expect the anticipated news will be released around Wednesday 11th or Thursday 12 January which still leaves 7 weeks until the Science Day on Wednesday 23rd February 2023, (https://avacta.com/avacta-to-host-therapeutics-division-science-day-on-23rd-february-2023/)
There will be minor fluctuation in the share price until then. Having come this far, sit tight, the big news will be here soon.
Have a Happy, Healthy & Prosperous New Year.
GLA
230 megaelectron volt milestone will target tumours at any depth
https://www.ukri.org/news/230-megaelectron-volt-milestone-will-target-tumours-at-any-depth/
Next steps
In collaboration with University Hospitals Birmingham, Advanced Oncotherapy will now finalise the required regulatory processes to achieve certification for LIGHT, aiming to treat first patients towards the end of 2023.