FSD Pharma (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative, inflammatory and metabolic disorders, is reporting that an arbitration panel has found that Syneos Health (NASDAQ: SYNH) failed to use commercially reasonable efforts in conducting its trial for FSD 201. According to the announcement, Syneos Health filed an arbitration proceeding against FSD Pharma in 2022. Syneos claimed that FSD Pharma owed Syneos Health $3,915,388.69 in damages as well as interest on that amount in relation to a failed phase 2 FDA trial for FSD 201; the claim also asked FSD to pay related legal expenses. The phase 2 trial was set up to enroll 350 patients in North America, and was eventually expanded to include 35 total sites in North America and several South American countries. Despite that, the announcement noted that Syneos Health’s track record of enrollment during the trial was “abysmal,” with fewer than 50 patients ultimately enrolled before the trial was terminated.
According to the announcement, FSD disputed that it owed anything to Syneos Health, countersuing the company and “making clear that it was not going to be bullied by a large CRO.” The case went to a three-arbitrator panel, which found “among other things, that Syneos Health breached its contractual obligations because ‘given Syneos Health’s poor success at patient enrollment despite its self-described “extraordinary” efforts, it was not commercially reasonable for it to continue to throw good money after bad in circumstances where the money in question was FSD’s,” the announcement stated. “The Panel awarded Syneos Health US$1,707,830.52 in damages plus interest for certain unpaid invoices essentially because FSD’s former management did not timely object and dispute those invoices in strict adherence with the boilerplate dispute resolution provisions in Syneos Health’s form agreement. The damage award is nevertheless less than 50% of what Syneos Health had demanded, as well as substantially less than what Syneos Health had offered to accept in settlement. The Panel also denied Syneos Health’s request for the payment of attorneys’ fees and litigation expenses. The award shows how small and midsize pharma and biotech companies can fight back against CROs [that] take them for granted and seek to impose huge costs on them while failing to perform their end of the bargain.”
To view the full press release, visit https://ibn.fm/QzOXf
About FSD Pharma Inc.
FSD Pharma Inc. is a biotechnology company with two candidates in different stages of development. Lucid Psychss Inc., a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-MS and UNBUZZD(TM). Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders. UNBUZZD is a proprietary formulation of natural ingredients, vitamins and minerals to help with liver and brain function for the purposes of potentially quickly relieving from the effects of alcohol consumption, such as inebriation, and restoring normal lifestyle. For more information about the company, please visit www.FSDPharma.com.
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