Strongly disagree. The FDA does have enough data/i
Post# of 148267
Entry into a Material Definitive Agreement.
On April 15, 2021, CytoDyn Inc. (the “Company”) entered into an Exclusive Supply and Distribution Agreement, as amended by Amendment No. 1 dated April 19, 2021 (the “Agreement”), with Chiral Pharma Corporation, a Philippine pharmaceutical company and subsidiary of New Marketlink Pharmaceutical Corporation engaged in the business of importation, sales, and promotion and distribution of a diverse specialty line of pharmaceutical and healthcare products in the Philippines (“Chiral”), pursuant to which the Company granted Chiral the exclusive right to distribute and sell within the next twelve months up to 200,000 vials of the Company’s product, Vyrologix™ (leronlimab), to treat critically ill COVID-19 patients in the Philippines under Compassionate Special Permit (“CSP”) or Emergency Use Authorization (“EUA”) from the Food and Drug Administration of the Philippines.
Under the Agreement, Chiral would hold the exclusive right to distribute Vyrologix in the Philippines for one year in accordance with the treatment protocols approved under the applicable CSPs or EUAs, and purchase all required quantities of Vyrologix in accordance with such CSP or EUA. The parties shall negotiate in good faith and use commercially reasonable efforts to enter into a Quality Agreement upon execution of the Agreement. Either party may terminate the Agreement for a material breach not cured within thirty (30) days of written notice or for convenience upon sixty (60) days-notice.