Jeg har prøvd å se etter i referatene om ledelsen i 2021 selv informerte om at Alpha37 var blitt eller skulle bli lagt på vent.
Fant da først denne uttalelsen på Q1-2020 pres. den 26.05.2020 - Nieba :
“So in more detail on our revised development plan. As mentioned, we focus exclusively on PARADIGME. We pause enrollment of patients into Archer-1 and LYMRIT 37-05 following the completion of the current cohorts. We then will start evaluating the results. We also pause all preclinical and research initiatives, our ongoing partnership with Orano Med on Alpha37 only after IND submission.”
Dvs. de sier at de ikke vil slutte å jobbe videre med Alfa37 sammen med OranoMed før de har laget en IND (Investigational New Drug) som er en søknad som må sendes til - og godkjennes av - FDA for å kunne starte med uttesting av en ny medisin.
Men så kan det nok stilles kritiske spm til fremdriften videre - der uker ser ut til å ha blitt til år for å få dette til…
Et kvartal senere på Q2-2020, 27.08.2020 fikk de spm om dette:
"In June, you said that Alpha37 research with Orano Med would be paused only after reaching IND submission. Has this been achieved? And if not, will you give updates on this going forward?
Lars Nieba:
Yes, we are working together with Orano Med, and we are working on the IND submission. So that is what we mentioned. So we – due to COVID, we had also a few different countries in the list that we couldn’t enter also. So we have a few weeks now where we still have to work on the IND.
Nytt kvartal, Q3-2020 den 19.11.2020:
"Has the Alpha37 IND been submitted? And if not, why not?
Lars Nieba (Executives)
No. It has not yet been submitted. We are working very closely with our partner, Orano Med, as you know. And due to COVID, we couldn’t easily travel between the sites and so we had a little bit of a delay. So we are working together on the current planning with Orano Med and when exactly to submit the IND, but we are in final stages of the preclinical work.
Tre måndere senere, Q4-2020 den 18.02.2021 og nytt spm :
Could you also say something about alpha 37, how that is going?
Lars Nieba:
Also that one, it was only one in the presentation yet, put our research activities on hold. So we are looking as soon as we do have a clear path forward there that we might want to go ahead or – but yes, as mentioned before, we focus everything on PARADIGME. And with that, we have put it on hold.
På de tre neste kvartalpres. Q1, Q2 og Q3 2021 nevnes ikke Alpha37 eller Orano.
Derimot avholdes en R&D dag den 30.11.2021 der Skullerud kan fortelle at
“Humalutin is already at the pre-IND stage. We are just finalizing the final steps for Alpha37 as well in the same frame of getting this to a pre-IND stage.” (I tillegg holder da Jostein Dahle et eget foredrag om Alpha37 og Humalutin).
Kommentarer i de neste kvartalene er da de jeg nevnte før i dag, og på Q1-2022 har de i det minste hatt en dialog med FDA der Skullerud sier at FDA “agreed with our approach” uten å si at IND var godkjent.
I referater etter dette kan jeg heller ikke se bekreftet at IND søknaden på Alpfa37 er godkjent - bare at de jobber videre med Orano MED.