Jun. 29 at 1:12 PM
$LPCN This slow crawl through the regulatory process is tough. Waiting for the IRB to weigh in on the outlier site. That decision probably informs the FTD/BTD decisions. Then we have to wait for the pre-nda meeting to get alignment on the path forward. All happening behind the scenes.
I hope they had productive meetings at Bio International last week. I'm not sure if they'll choose to self fund the next trial or if they'll look for a development partner. I expect they'll wait until they know for sure what the path forward is before making a decision.
I imagine they would have had several companies looking to talk to them about the trial results and oral brex, and maybe some out-licensing discussions about 1148. Wish I could have been a fly on the wall for those discussions, but I'm still confident this will be worth the wait.
Not expecting much for news over the summer outside of Tlando canadian approval, but hopefully things pick up mid to late Q3.