Nå som børsen er stengt og helgeroet har kommet så kan jeg dele noen ting jeg kom over. Legger det her da jeg ikke er sikker på hvor fundamentalt det er enda.
Under Q2 2020 skrev de:
The company has received regulatory and ethics approvals for USA, South Korea, Taiwan and 10 European countries; Norway, Germany, France, Spain, Italy, Belgium, Poland, Sweden, Denmark and Finland. The remaining countries in Europe are UK and Ukraine .
Fra børsmeldingen i august :
We have initiated work to include Ukraine in the study and are also considering further Asian countries.
Så hva kan vi finne om Ukraina? Jo, hvis man graver litt hos «Міністерство охорони здоров’я україни» kan vi finne … ok, jeg brukte Google Translate herfra: «Ministry of Health of Ukraine»
ORDER OF THE MINISTRY OF HEALTH OF UKRAINE OF DECEMBER 15, 2020 №2917
About carrying out clinical drug testing and approval of substantial amendments
Så hva er det herr Maksym Stepanov ber om?
I ORDER:
To allow clinical trials in accordance with the Annexes (Annexes 1 - 4).
Spennende. La oss finne ut hva «додатки 1-4» kan inneholde. Vel i nummer 1 finner vi:
List of protocols of clinical trials of medicinal products and significant amendments to the protocols of clinical trials considered at the meetings of HEP № 26 of 10.12.2020, STC № 50 of 10.12.2020, which received positive expert opinions.
Kan det være? Vi fortsetter videre i dokumentet:
Multicenter, randomized, open-label phase 2 study to evaluate the safety, tolerability, and efficacy of fimaporfin-induced photochemical internalization of gemcitabine in conjunction with chemotherapy with gemcitabine / cisplatin versus the use of gemcitabine alone / 18, final version 3.0 (global amendment 2) dated July 13, 2020, sponsored by PCI Biotech AS, Norway Applicant - Limited Liability Company InnoPharm-Ukraine Contract Research Organization
Oi. Hva kan vi forvente av dette?
Name responsible researcher
Name of the place of clinical trial
MD, prof. Dudnichenko OS
State Institution "Institute of General and Emergency Surgery named after V.T. Zaitseva of the National Academy of Medical Sciences of Ukraine ", Department of Purulent Surgery for 25 beds with a 6-bed intensive care unit, Kharkiv Medical Academy of Postgraduate Education, Department of Oncology and Pediatric Oncology, Kharkiv
Ph.D. Yareshko VG
Municipal non-profit enterprise “City Hospital № 3” of Zaporizhia City Council, Department of Surgery №1, State Institution “Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine”, Department of Surgery and Minimally Invasive Technologies, Zaporizhia
Tøft. Finner vi noe mer i appendix nummer 3 også?
Amphinex (amphinex, fimaporfin, fimaporfin) (Fimaporfin; fimaporfin); 2 ml of Amphinex (fimaporfin) at a dose of 26 mg / ml, solution for intravenous injection; 26 mg / ml (milligrams / milliliter); PCI Biotech AS, Norway; Curida AS, Norway;
Gemcitabine (gemcitabine, gemcitabine medac, Gemcitabin medac) (GEMCITABINE HYDROCHLORIDE; Gemcitabine); powder for solution for infusion, each vial contains 1000 mg of gemcitabine; 38 mg / ml (milligrams / milliliter); Medac Gesellschaft fur klinische Spezialpraparate m.b.H., Germany
Det kan se ut som at vi har funnet godkjennelsen av RELEASE i Ukraina, men https://clinicaltrials.gov/ct2/show/NCT04099888 er ikke oppdatert så jeg ser ikke bort ifra at det kan være noen humper på veien fremdeles. Men hvis dette er og jeg ikke misforstår så finner vi kanskje de to lokasjonene under «Contacts and Locations» snart?