Member Info for Muck165

Noticed filed this at companies house today

https://s3.eu-west-2.amazonaws.com/document-api-images-live.ch.gov.uk/docs/uG-u4AHYYYuIPjwpPZw4eqVa5HREuuIX8QnWcc7QD5E/application-pdf?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=ASIAWRGBDBV3KSG2AFJP%2F20220921%2Feu-west-2%2Fs3%2Faws4_request&X-Amz-Date=20220921T215919Z&X-Amz-Expires=60&X-Amz-Security-Token=IQoJb3JpZ2luX2VjENb%2F%2F%2F%2F%2F%2F%2F%2F%2F%2FwEaCWV1LXdlc3QtMiJHMEUCIHA%2FFHpvgFj0YCy3whCRTubcZjJT9hJuXLVwJ9Mwou%2FlAiEAo5X2yiqWb4nR5jdjmatOAIKi7Vm1yiWR9uaj1IRj9C8qzQQIfxAEGgw0NDkyMjkwMzI4MjIiDFuQ4W5jXgELiFwzXiqqBMNqhZkUKdt9YIEW7yWrBjs%2FnD4O3CeszNT2b4JS0CvEd3fTROVqH4IFaPQFuviFhaJyFUgOiSdqwu5HaxzUbOPvIjBVSRxSM6dnMrcSwYWcxBRdtzIcd4QRolTLC77gR9A2AuC4L0FqRX4BNLwRn6zYKqW0wT5n48uvT00j%2B4Lt5ZfjEFR1Bo4iwKaeCiBd%2BXiqalLLL1f5E24Th%2FDLMlZsJNH4c78txu6FCpGuB5Yg4GknDi1hQdv%2Fyutx%2BkF4%2BZGb9cMybX8eHTIULMO7YhOlsjzulon1q4PDoBraVRESQ91ekraKZR8ezkcMTxd1dvfujJyixqiwdW1zNWhxMGB51TX9QKDhcuToB%2BTKnyXX6Gi9XkmuLhkJLPEYU56ngz3HVAsg4fPdlpnm3o0QtW8cJkhUgiCd6s8a%2BlRO7K%2BuANvZn5YC57pazlKtCorAGecQVZAoujr****scd1Ia57VJ%2BpUFAx1xBGvNmwUUtmkOP%2FvOHpNXlW5vY1BK2rkFobusgKzXesMhnLiPGnmC0Ae2znlVpqJ3ZfmsQoIkky0ZyVo6T%2BFKZ0M5bQ3llx%2BkqboH1Wk05XGmBlOBM9uHLeyUGuPEIyrSHGQA5AEXWF3yvjkKiUS2sanbTnSeelsLM1SkKeIc5Up8UTWSXQDPBL7Ny2J8OfCvHiWbOLI4zskCvtpdQOO%2BIz0vRjYaD%2FE9HV0WeifZ5Mu%2Frq0w8y132BEoqfy3M9KPviJMNeIrpkGOqkB5z%2BfPj%2BOd9JlQyDGQxl7AQbc1XCLTNyvh%2FdAcLWs4z6tTSsdJLlkzDpmgFRhF9l9YNApNnvRexcqb6llRy7hFdorEop8FMvN5bRht4jgIUIeRoenAMH7f822RQahlCqWd%2BDIJsvhDAiP1MhlC4PkYutNZBAkPAuJOa%2FYT5I%2BUWxL8hogU5XxzgzK4j0AE1mgugfbEz%2FjzO56u0CK%2BfmQdcybFfHnebVkAw%3D%3D&X-Amz-SignedHeaders=host&response-content-disposition=inline%3Bfilename%3D%2212275099_sh01_2022-09-21.pdf%22&X-Amz-Signature=bfd3a93db45729e5f81385e17ed4c86a74327be521b1c159c09f2f12a9ca2f84

I really am no expert in this so happy to stand corrected by anyone, but it looks to me like more preferred stock has been issued in a second funding round. If that’s right then maybe there is something in Vatic - after all, why would any investor, likely a VC, invest more in a “dead duck”.

Would be nice to get something from ABDX confirming the current Vatic state of play.

Great RAH - so why the stress by AS on pre-clinical in the ODD RNS. Makes no sense to me. In fact makes no sense to reference pre clinical at all.

Whatever, I do agree that the ODD app must have had clinical data.

I think you’re most likely right RAH. If there could be a doubt, I suppose it’s that we may not have had clinical data relating to the actual rare condition that ODD was granted for, ie STC. But even then, surely any clinical data would have been relevant to show the action of the platform.

An update

Paul Trainor, Head of Manufacturing/end to end supply chain, left Vatic last month and doesn’t appear to have been replaced (or found other work).

Vatic is a dead duck in my opinion.

Surely it’s just dropped to a support level?

Good to see councils granting planning for Geothermal projects…

Hopefully the Environment Audit Committee will recommend further cutting of planning red tape when it’s finished it’s current inquiry.

https://www.newcivilengineer.com/latest/green-light-for-geothermal-power-plant-in-cornwall-20-09-2022/

Tell that to my teenage son

If you’re new to this the my advice would be to leave this one alone; it’s a massive risk. If you fancy a punt, do it with what you can comfortably afford to lose. And if that comes off, for god sake don’t think you’ve suddenly become an expert that can’t fail to make money on everything else you dabble in. You won’t!

Hmm….not too sure about this myself.. Optimus seems to be targeting drugs that might be taken for years (like ADC’s) where toxicity over that period cannot be properly assessed in P1 trials. Hence why the FDA are focussing on the optimal dose balancing efficacy with Safety/tolerability, rather than just MTD. AVA6000 is not, as as I understand, intended to be given for prolonged periods - it is simply a better targeting method for dox, still to be given over a relatively short period.

All that said, I have wondered if the AVCT move from targeting MTD to a “recommended” dose for the DE phase had more to do with Optimus, to find a dose balancing efficacy with safety and data, rather than just an inability to ratchet the dose to a level until we reached DLT.

Thanks gmcc - shame they didn’t finish the piece to explain DE from 160 to 200.

I think it’s safe to say Avacta are aware - I came across it because Julie Charlton, our Head of Portolio Project Mgmt, liked a post about alternative P1 dosing models. One of the comments to that piece was interesting, from Glen Clack, Honorary Prof of Translational Medicine at Sheffield Uni..

“As I understand it, from a recent FDA webinar on dose optimisation I.e. Porject Optimus, ‘Phase 1 is dead in oncology’; a point I have strongly agreed with for more than 15 years. There has to a an ‘efficacy’ vector to dose finding, rather than just PK and safety/tolerability.”

Apologies if already discussed, but I see the FDA began Project Optimus recently to try and deal with inadequacies in the standard design of oncology trials. This article lays it out well, and I wonder if others have any thoughts about what impact, if any, this will have on the AVA6000 trial.

https://www.appliedclinicaltrialsonline.com/view/understanding-project-optimus

https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus

The GLP used Freedom of Information law to force the UKHSA to release the names of all companies granted access to the VIP route for test and trace - they published it yesterday and you should be able to see it here

https://drive.google.com/file/d/1HRt5NJSOWiyU8rB2PAZBdaJuC-iynEI2/view

One company not on the list - Abingdon Health.

Agree Timster, and if there is a placing then the amount of discount (if there was one) might be the best indicator yet about “is it working”.

Personally I don’t see any short term placing worries anyway.

I agree with you RAH - AVA6000 has been designated an orphan drug. There is no further review or approval process in respect of that designation. Would be good if AVCT could confirm.

I’m a bit confused - my reading is that the designation process is a separate thing from the approval/license process, and that this new listing confirms we have been duly designated as orphan. The “orphan” drug just hadn’t been approved.

But then it’s late and I’m tired!

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products

From the Takeda Ventures site

“ Takeda Ventures, Inc. is a part of our Center for External Innovation (CEI), an integrated, global team driving innovation for Takeda R&D”

Apologies - 7 imported.

It does seem that this public list isn't updated as soon as approvals are given so I am not sure its necessarily a reliable up to date source.

The list of Taiwanese Covid tests with EUA approval was updated yesterday (the last update was May)

https://covid19.mohw.gov.tw/en/cp-5281-63752-206.html

I'm assuming the Arise agreement relates to Antigen LFT's, in which case since 6 June (the date of the Arise RNS), there have been 2 domestic and 4 imported antigen test approvals, none of which immediately strike me as something we might be manufacturing, although I could be very wrong.

Just some more..

https://www.menoguide.co.uk/

Worth looking at the posts here https://www.linkedin.com/company/agile-life-sciences/posts/?feedView=all