The FDA advised Telesta to file with existing data set from Phase 3 and partial phase 3B. Then they decided to give Telesta Priority Review as well. If they wanted more data they would have said so months ago. Beside Valstar was approved at 10% CRR on a smaller trial than MCNA's. They also had huge safety issues. On Papillary (Papillary is 90% of all Bladder Cancer patients) Telesta had CRR of 35% at 1 year with only 1.5% of patients having mild to moderate AEs. Valstar was 30% AEs. If you are refractory to BCG (60% are within 1 year) they remove your bladder or into Palliative care to die.
The OTC Pinks is what you are stuck with until after the AGM in a week. We are voting on a share consolidation to uplist to the nasdaq. COO said we will not do a SC until FDA approval is in place. They have hired some real industry heavy weights to scale up production and distribution. so either they are really stupid or bold, or are pretty certain they are getting AdComm thumbs up in 2 weeks and FDA approval in February.
The Current CEO Michael Berendt (from the US) took a drug from Phase 1 to a billion in revenue. So pretty sure he knows what he is doing. Not to mention Consonance capital bought into 20% of this company at market with no warrants!! Find me another instance where an institutional investors does that without a warrant or half warrant attached.