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XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT

XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT

Form 8-K - Current report - Item 7.01 Item 8.01 Item 9.01

Acasti Pharma Inc - Class A

Announcement: ACST 8-K Special Filing

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Form 8-K - Current report - Item 4.01 Item 9.01

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Form 8-K - Current report - Item 2.02 Item 9.01

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XBRL TAXONOMY EXTENSION CALCULATION LINKBASE DOCUMENT

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Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Acasti Pharma: A premier, late-stage specialty pharmaceutical company with potential to improve clinical outcomes. Management’s discussion and analysis of financial condition and results of operations shows the company's strong focus on developing drugs for rare diseases utilizing previously approved drugs that have established safety profiles & clinical experience. The successful completion of the merger positions Acasti with two Phase 3 ready drug candidates and additional products in the clinical and preclinical stage. With an intellectual property portfolio of more than 40 granted and pending patents worldwide, Acasti aims to apply proprietary formulation and drug delivery technologies to achieve better clinical outcomes for patients. 

Forward-Looking Analysis: Developing drugs for rare diseases can often allow for clinical trials that are more manageably scaled and may require a smaller, more targeted commercial infrastructure. Rare disorders represent an attractive area for drug development, and Acasti has an opportunity to utilize previously approved drugs to potentially address significant unmet medical needs. Acasti’s ODD status, awarded to its first three drug candidates currently in clinical development, provides exclusivity in the US for seven years post-launch, faster regulatory review, tax credits of up to 50% of clinical development costs in the US upon market approval, and waivers of the new drug application (NDA) fees, which could translate into savings of $1 - $2 million. Acasti remains confident in its ability to leverage its novel drug delivery technologies and advancements to meet critical unmet medical needs.

Announcement: ACST 10-Q Quarterly Report

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