According to the lawsuit, the IPO documents failed to disclose that the Food and Drug Administration (“FDA”) had, prior to the filing of the IPO documents, imposed a clinical hold, and in fact, contained statements indicating that it had not. Given that the IPO closed on July 2, 2021, more than thirty (30) days after the Company submitted the Investigational New Drug (“IND”) applications for its two immunotherapy product candidates, investors were assured that no clinical hold had been issued and clinical trials would commence.
The Company, however, had received communications from the FDA on June 16 and 17, 2021, informing it that the FDA was placing the IND applications for its two candidate products on clinical hold. The IPO documents failed to disclose this information, instead representing that clinical testing was expected to proceed in the third quarter of 2021. Clinical testing did not proceed in the third quarter of 2021, nor was it likely given the FDA’s imposition of a clinical hold. When the true details entered the market, the lawsuit claims that investors suffered damages.
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