Som en oppfølging av QA i Q2-presentasjonen om IOVaxis og utsettelse så har jeg fått denne mulige forklaringen:
The preclinical data required by the NMPA causing the delay could be about the ethnic difference data.
After NMPA decided to accept overseas clinical data for application a couple of years ago, one of the key issues is the risk assessment of ethnic differences. If there is no risk of ethnic differences, the overseas clinical data can be used, but if there are recognized risks or potential risks, bridging trials, dose adjustment, or even regional effectiveness and correctness trials will be required.
As of ethnic difference, they could be internal and external factors to be considered.
The internal factors focus on gene polymorphism, age, sex, height, weight, lean body constitution, body composition, and organ dysfunction. External factors include residents’ living environment, culture, and behavior. Particularly important is the dependence on clinical good practices in other regions and the practice of clinical trial design and implementation.
Race-sensitive compounds refer to compounds whose pharmacokinetics, pharmacodynamics, or other characteristics indicate that internal and/or external race factors may have a clinically significant impact on safety, effectiveness, or dose effect.
When there are ethnic differences, the NMPA usually requires bridging studies. But at this stage, they are probably trying to collect data to prove there is no ethnic difference.
Det er selvfølgelig ikke mulig å vite om dette er en riktig vurdering eller ikke, men siden det finnes tegn på at IOVaxis har og fortsatt forsøker å hente penger så er det lite sannsynlig at selskapet har satt i verk det som ovenfor kalles “bridging studies” dersom disse er kapitalkrevende.
