Forsøk på et nøyaktig bevis for at Ling i DnB har misforstått, og tror tiden det tar for Nanov er mye lengre enn det Renoldi uttrykker.
DnB “With a 3-month follow-up after the treatment and four weeks from the last evaluated patient to the top-line data presentation”
Spørsmålet her er jo om det trengs en 3 mndrs. follow-up etter at pasienten har fått Betalutinsprøyten og deretter 4 uker etterpå for å greie å evaluere.
Pasienten får først predosering. Forutsetter at Pet-scanning er utført. Deretter en kort periode før Betalutin gis. Deretter trengs ca. 2-3 uker for å se virkningen på svulstene. Så ny Pet-scanning og sammenlignende bildeanalyse, som bør være svært raskt gjort. Så er 3+1 mndr. nødvendig for å gjøre en preliminær read-out?
(Dette gjelder jo kun siste 4-5 pasienter fra siste måned. For tidligere pasienter kan det brukes lengre tid.)
Marco sier vel her* at det IKKE er nødvendig, men at det kun trengs 3-4 uker fra pax er “enrolled”? Enrolled betyr vel her fra predosering.
“When the patients of the last month will be enrolled, there will be a period of probably 3 or 4 weeks for the last patients to be reviewed and cleaned and to make sure we collect the independent assessment, but I think its almost parallell to the completion, to the completion to the enrolment and dosing of the last patient. And again the 4 weeks time for the collection of the independent review of the scans will only affect the last 4 patients.”
*Transcript fra Nanos Q121-call 29.26
Spørsmål: ”How much time do you think you need from readout of top line data from paradigme to a completed BLA for Betalutin to be sent to the FDA?”
Peter Braun: ”Marco, do you wanna handle that one?”
Marco: ”Yeah, of course. In order to have validated data, so clean data you need for the regulatory submission, you clearly need and we mentioned this on the previous quarter- call, 6 to 8 week, but this may not be required in terms of providing top line data. So, I think you need to consider what is the reason why, for what scope you are communicating the data, but its about 6 to 8 weeks to complete the cleaning of the data in order to be able to file them for your BLA-package.
Transcript fra Nanos Q221-call 24.13 inn i callen:
Spørsmål fra IR-mann: ”Can you give any more granularity on how long after completing recruitment results will be ready to be released.”
Malene: ”Marco, I think you answered that on our last call, so?”
Marco: ”Yes, I think data, in particular independent review of the scans are being progressed as we move forward, so I think what happens is at the end of the last month, so when the patients of the last month will be enrolled, there will be a period of probably 3 or 4 weeks for the last patients to be reviewed and cleaned and to make sure we collect the independent assessment, but I think its almost parallell to the completion, to the completion to the enrolment and dosing of the last patient. And again the 4 weeks time for the collection of the independent review of the scans will only affect the last 4 patients.”