Strongly disagree. The FDA does have enough data/i
Post# of 153815
(Total Views: 432)
Posted On: 04/21/2021 10:08:40 PM
Re: Goosebumps #87376
Strongly disagree. The FDA does have enough data/info to grant an EUA to Cytodyn for Leronlimab. We need to wait and get more data? Our hopes are in an EUA from the American FDA? I think not. There is another pathway to get Leronlimab in the hands of doctors and hospitals, soon, rather than to wait for more data and more trials, and I also think everyone reading this comment of mine, knows what pathway I'm expecting Cytodyn to follow. The Philippines and/or any other nation. The positive results will create spreading awareness and expanding demand, added fuel on this fire is of course, the massive number of deaths and the stats of new covid19 cases. Hong Kong, Indonesia, Chile (we think?) are also asking for LL for compassionate use. And now we know that the agreement with Chiral is "to sell" LL to the Phillipines for Compassionate (dated April 15th and amended April 19th)
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.
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.
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