Dear Dr. Petrov,

I hope this email finds you well. Once again we would like to express our sincere gratitude personally to you and company Eli Lilly for considering the opportunity for emergency use authorization for Bamlanivimab in Georgia. As we mentioned earlier this is one of the most promising methods of COVID-19 treatment and we would highly appreciate your generous collaboration in this matter.

We do apologize for our delayed response due to our very busy schedule over the last weeks.

As we understood from our teleconference with you, company Eli Lilly considers the opportunity to donate some quantity of Bamlanivimab to Georgia.

In order to obtain approval from the regulatory agency to conduct a clinical trial, together with ministry of health officials we have already started preparation work for the submission package. For this we kindly ask you to provide necessary documents on the investigational product, including FDA approval, preclinical materials, GMP certificates and other relevant documents. 

Also, it has been decided that our center (Infectious Diseases, AIDS and Clinical Immunology Research Center, which is Georgia’s referral institution for treatment and care of all infectious diseases, including HIV/AIDS, viral hepatitis and COVID-19) will be responsible for receiving Bamlanivimab from your company. In this regard it is necessary to formalize an agreement between our center and company Eli Lilly. Tomorrow we will provide you a draft of the agreement and would appreciate your comments. My colleagues (cc'd) are ready to work on the agreement document.

Thank you very much in advance for your kind consideration.

Best regards,

Tengiz Tsertsvadze MD, PhD

Director General

Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi

 

On Sun, Jan 31, 2021 at 1:49 PM Alisa Tsuladze <atsuladze@moh.gov.ge> wrote:

Dear Dr. Petrov,

First of all we would like to thank you for your letter and your kind suggestion to help us receive Bamlanivimab. We have discussed this opportunity with the  COVID-19 national clinical group of experts and are interested in all novel monoclonal antibodies in general and Bamlanivimab in particular. We think that this is one of the most promising methods of COVID-19 treatment.

However, we will need more information about the medicine, such as the available interim results from different countries where it is being used. Also we would like to request more information about organizing supply of the medicine to our country.  As for the local regulatory approval, we will proceed with the authorization as soon as we have additional information. 

For this reasons we think that it would be helpful for both sides to organize an online meeting to discuss all the matters.

Thank you for your time and consideration, looking forward to your reply.

Respectfully,

Alisa Tsuladze, MPH

Health Policy Division

Policy Department 

Ministry of Internally Displaced persons from 

Occupied Territories, Labor, Health and Social Affairs of Georgia

Tel.: +995-32-2-51-00-38  ext 1125