Must Read - Extremely Detailed information on Antibe https://www.insolvencies.deloitte.ca/en-ca/Documents/en-ca-insolv-Antibe-ApplicationRecord.pdf
I'll paste this on CEO, Stockhouse and the Discord server. Feel free to post the link to wherever else you might think is relevant.
A lot of the other links so far seem to be a brief overview of what happened. The PDF I linked contains so much minute, extremely detailed information (exact dates when certain contracts started, when people were contacted). Gives potential reasons why directors resigned (how much they're liable for and how much their insurance covers). This is the most detailed information I've ever seen about Antibe, definitely a must read if you're invested.
From the FDA meeting (not the within 30 days letter) it gives the reasons the FDA put a hold (p. 45) to the reasons Antibe lost to Nuance (P. 49 - 53). That is perhaps some of the most interesting information for investors? You can also get a sense whether you think Nuance is trying to get ATE's IP or just trying to get as much of their money back as possible. Definitely read it over for yourselves, but a brief summary is as follows:
FDA advised: "They felt that the existing non-clinical data did not demonstrate an adequate safety margin given the initial clinical dose that Antibe planned to use. However, the FDA further advised that it uses a conservative estimate for potential exposure, and that if Antibe could show that the actual exposure would be lower, it could submit this information to the FDA in response to the forthcoming FDA Hold Letter; and
They believed they did not have sufficient data to support some of the assumptions within the DILIsym model, and felt that there was not enough data provided by Antibe to justify those assumptions."
Losing arbitration to Nuance is a lot longer to quote (read it over yourself), but my summary... Nuance did not do very much (minimal) due diligence:
"To Antibe’s surprise, the Nuance team requested virtually no materials for due diligence. Nuance did not request any meetings with key Antibe personnel to ask questions and obtain further information, or ask for many documents and categories of documents that are standard in due diligence. Critically, Nuance never asked for all of Antibe’s regulatory communications, or for Antibe’s correspondence with the FDA or with Health Canada. Nuance asked only a few questions in relation to the Drug and the documents in the Data Room and then advised it was prepared to enter into the agreement."
"The Data Room reports show: (i) Nuance representatives only spent 31 hours in the Data Room and looked at approximately 10% of the documents; (ii) the CMO of Nuance only reviewed the first few pages (the synopsis) of certain key documents in the Data Room, including the Phase 2B Effectiveness Study, and (iii) the Nuance employee in charge of regulatory issues spent less than 30 minutes reviewing correspondence between Health Canada and Antibe."
"Based on my review of the transcripts of evidence given in the course of the Arbitration, it appears to me that neither Nuance’s CMO nor other Nuance personnel were aware that the LTEs observed in the Drug’s clinical studies were a risk and did not recognize that the LTEs were a cause for concern."
The reason Antibe lost arbitration (they didn't include correspondence with Health Canada):
"At the same time, in late January 2021, Antibe’s exchanges with Health Canada were ongoing, producing the Health Canada Correspondence. At the time, Antibe did not consider including the Health Canada Correspondence in the Data Room, in part because (i) the LTE issues on which Health Canada based its communications were widely covered in the clinical documents in the Data Room, (ii) Antibe’s withdrawal of its application did not constitute a material change or adverse event that Antibe needed to report because Health Canada had not made any decision on the merits of the application and had invited Antibe to re-submit its application following the completion of the mini-pig study, (iii) it is common for regulators to make such inquiries and provide such feedback, and (iv) Antibe considered the Health Canada questions easily answered (and they were in fact easily answered, and Antibe subsequently received approval to start the study, as outlined above)."
Also, if you think Dan's an idiot for agreeing to binding arbitration and agreeing for it to be held in Singapore, it's because: "Pursuant to the Nuance License Agreement, the governing law for any dispute between the parties was New York law, and the seat of the arbitration was Singapore."
Anyways, there's lots of great, extremely detailed information in there, I highly encourage you all to read it over.