GREY:ATBPF - Post by User
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Jjjj12345on Mar 17, 2021 1:53pm
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RE:RE:RE:Fireside chat at Maxim event - starting now
RE:RE:RE:Fireside chat at Maxim event - starting now first time hearing confirmation that they would sell Otena, always seemed like they wanted to focus on partnering.
Straylight wrote: Sure so the format of this one was straight question and answer instead of running through a deck which was nice to see.
This is my interpretation of the discussion:
Partnering: he said talks are underway and will only expand. He said "partnership announcements could happen at any time". So read into that what you will.
Phase 3 - latter half of this year. They made a tactical decision fall 2020 of when to try to start based on vaccine timing. 50 American sites, they have most enabling studies either finished or in progress. Scheduling meeting with the FDA in the fall (I'm interested in exactly when that means).
Lowest dose - they are running AME studies and will use that to determine lowest dose (Dan mentioned this is a good problem to have since they seem to be able to run lower than 150mg) based on the absorbtion studies they will tailor their multi-arm phase 3 with those doses in consultation with the FDA.
Nuance - turned heads in the industry with the positive terms of the deal. They are lining the phase 3 approval in China to align with when phase 3 will finish in USA since they will use some US data for chinese regulatory. They have veto control over the terms of the trial with Nuance but they are working very nicely together. Will include a small number of chinese nationals to meet china p3 requirements.
Selling Otena - they are open to selling/partnering for it this year. They mentioned the longer they drive it the more value it generates. Ability to take it all the way to commercialization if they want (seems they will sell for the right deal but they want a strong negotiating position. Bad deal = ATE commericalizes it).
NASDAQ - key goal for the team. They meet all criteria for listing, legal prep is done, have directors with US listing experience. Now it is a matter of strategy to choose when to go. Mentiond it will happen in the next twelve months (seems like it will be fall based on previous comments).
Research - collaborating with a well known American university for moving the pipeline forward. They are focused on the next set of drugs - costs a couple million $ CAD to move them into human trials so they are moving towards that. They mentioned the John Hopkins paper linking HS to Alzheimers.