RE:Another presentation With these presentations, it smells a potential pp in few months so they can advance the GBM indication, given how slow the NMIBC Ph. 2b is advancing, because of the COVID-19 clogging the ICUs and hospital resources.
I don't expect them to have additional data regarding the Ph. 2b before they reach at least 90-day data on the 20-25th patient, if not 12 month data, for them to sit down with the FDA, despite the FDA FastTrack approval, even though the FDA FTA allows for more frequent meetings. To have meetings, you have to have data and that independent board won't check every patients, one at a time. So that would be in line with Dr. Kulkarni's comment at the AGM "See you next year".
What the FDA wants to see is mostly durable response. That's what matters most. But Breakthrough designation could maybe granted if there would be a very high ratios of CR (90 days) from many of the patients that have received the full dose.