The company said a special meeting of Altum shareholders, more than 72% of whom have signed a lock-up agreement, is scheduled for July 29 to approve the merger. The results of the vote will be announced shortly thereafter.
BetterLife also said Altum is making progress with the US Food and Drug Administration (FDA) following its May request for a pre-Investigational New Drug (IND) meeting on AP-003 (Interferon Alpha-2b for inhalation).
The FDA has responded and provided clear and implementable guidance that can lead to a successful IND filing upon completion of one additional nonclinical study, BetterLife said.
"We are pleased with the feedback from the FDA which provided guidance on non-clinical, CMC and clinical aspects of Altum's proposed plan to initiate an AP-003 COVID-19 development program," Ahmad Doroudian, CEO of BetterLife and Altum In a statement. "The FDA also encouraged further interactions as we near the IND filing."
Doroudian said the FDA guidance “clearly lays out the steps that we have to take to move AP-003 forward so that it reaches the clinic for the treatment of COVID-19.” He added that the company is working towards starting clinical trials in the next two to three months.
The CEO said the Vancouver-based company will release more detailed clarification on the feedback from the FDA and on its planned human trials immediately after the merger vote.
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