|6 Months Ended|
Jun. 30, 2020
12. Subsequent Events
On June 30, 2020 the Company submitted an Investigational New Drug (IND) application with the FDA for SYN-020, an oral formulation of recombinant intestinal alkaline phosphatase (IAP). On July 30, 2020 the Company announced that it received a study-may-proceed letter from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1 single ascending dose study in healthy volunteers designed to evaluate SYN-020 for safety, tolerability and pharmacokinetic parameters. The Phase 1 clinical program is intended to support the clinical development of SYN-020 in multiple indications, including the treatment of radiation enteropathy secondary to pelvic cancer therapy.
On January 7, 2020 the Company held a Type-C meeting with the FDA to discuss the clinical program requirements needed to evaluate safety, tolerability and potential absorption into the systemic circulation (if any) of SYN-004 (ribaxamase) in adult allogeneic HCT recipients. On July 30, 2020 the Company received written notification from the FDA informing it that they determined the Phase 1b/2a clinical program in adult allogeneic HCT recipients is safe to proceed per the submitted clinical program protocol.
The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef