“The recent announcements of the FDA’s approval to reduce the study size to 70 patients, the private placement financing, and FDA-agreed study protocol changes, provide strong momentum to support the NEPHRO CRRT study execution,” stated Vince Angotti, CEO of Talphera (TLPH). “These developments, coupled with the addition of new sites with higher enrollment potential, two of which have just started screening patients with six more sites expected in the first half of this year, support our belief that we will complete the study by the end of 2025. In addition, clinicians’ continued enthusiasm for Niyad’s profile reinforces our confidence in its potential to fill a significant unmet need in the CRRT market,” continued Angotti.
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