ISLA101 is a repurposed drug. According to the IPO Prospectus, it has a "well known safety profile".
So why does the FDA now require an additional P1 ascending dose safety study? Could it be because of the new manufacturer? To me it sounds like an overabundance of caution by the FDA.
To what extent does this FDA decision negate the benefit of the strategy of using a repurposed drug? At least we can be confident of the outcome of the new P1 trial.
Also, should ILA management have anticipated this FDA decision by undertaking pre-IND consultations? It seems to have come as a surprise to them.
Not happy.
ILA Price at posting:
13.0¢ Sentiment: Hold Disclosure: Held
