..and another w/Georgia - (clipped) ------------
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Posted On: 05/06/2021 1:59:21 PM
..and another w/Georgia -
(clipped)
You also asked about the Georgia EAP that NeuroRx recently announced.
We are pleased that the Georgian Ministry of Health is interested in initiating an expanded access program in their country to provide aviptadil to COVID-19 patients with respiratory failure.
Despite the availability of vaccines against COVID-19, there remains an urgent need to provide patients with treatments, particularly those with severe disease.
“Thank you for your e-mail. We will address the questions to which we are able to respond.
Regarding the U.S .EUA, under the collaboration agreement, NeuroRx is responsible for the clinical development of RLF-100 in the U.S. NeuroRx has informed us that they are in the process of applying for an EUA. We cannot speculate on how long this process will take.
Regarding the dispute with NeuroRx, Relief is actively and constructively striving to find an amicable solution to resolve the dispute.
Related to this, Relief has always been willing and able to fund the inhaled trial, upon NeuroRx presenting a detailed budget containing appropriate line items and underlying amounts and upon NeuroRx answering reasonable questions that we have posed to them asking for more details about their proposed trial budget.
This has not happened to date. Nevertheless, we would also like to point out that Relief has already funded substantial expenses associated with NeuroRx's U.S. inhaled trial.
You also asked about the Georgia EAP that NeuroRx recently announced. We are pleased that the Georgian Ministry of Health is interested in initiating an expanded access program in their country to provide aviptadil to COVID-19 patients with respiratory failure. Despite the availability of vaccines against COVID-19, there remains an urgent need to provide patients with treatments, particularly those with severe disease.
Also, please note that Relief has entered into a Collaboration and License Agreement with Acer Therapeutics for worldwide development and commercialization of ACER-001. For more details on the agreement, we refer you to the press release dated March 22, 2021.”
(clipped)
You also asked about the Georgia EAP that NeuroRx recently announced.
We are pleased that the Georgian Ministry of Health is interested in initiating an expanded access program in their country to provide aviptadil to COVID-19 patients with respiratory failure.
Despite the availability of vaccines against COVID-19, there remains an urgent need to provide patients with treatments, particularly those with severe disease.
“Thank you for your e-mail. We will address the questions to which we are able to respond.
Regarding the U.S .EUA, under the collaboration agreement, NeuroRx is responsible for the clinical development of RLF-100 in the U.S. NeuroRx has informed us that they are in the process of applying for an EUA. We cannot speculate on how long this process will take.
Regarding the dispute with NeuroRx, Relief is actively and constructively striving to find an amicable solution to resolve the dispute.
Related to this, Relief has always been willing and able to fund the inhaled trial, upon NeuroRx presenting a detailed budget containing appropriate line items and underlying amounts and upon NeuroRx answering reasonable questions that we have posed to them asking for more details about their proposed trial budget.
This has not happened to date. Nevertheless, we would also like to point out that Relief has already funded substantial expenses associated with NeuroRx's U.S. inhaled trial.
You also asked about the Georgia EAP that NeuroRx recently announced. We are pleased that the Georgian Ministry of Health is interested in initiating an expanded access program in their country to provide aviptadil to COVID-19 patients with respiratory failure. Despite the availability of vaccines against COVID-19, there remains an urgent need to provide patients with treatments, particularly those with severe disease.
Also, please note that Relief has entered into a Collaboration and License Agreement with Acer Therapeutics for worldwide development and commercialization of ACER-001. For more details on the agreement, we refer you to the press release dated March 22, 2021.”
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