FDA Discussions

Hi all,

Following yesterday's news of the clinical hold (and having time on this public holiday to sift through old announcements and the FDA website), I felt a lot more comfortable that things are on track. I just wanted to get my thoughts down here, noting that Bisantrene is a long-term project.

1) The RAC announcement, regarding filing of the IND on 25/03, did indeed note that the IND submission was extensive at 2,000 pages and was the culmination of 3 years hard work. It did indicate that the FDA would likely extend their review beyond the normal 30 days timeframe.
2) I just researched the FDA conditions for IND approval, and it notes that it will initially contact the sponsor (RAC) regarding putting approval on a clinical hold, pending further questions. It indicates that once the formal questions are received by RAC in the form of a letter, it then has 30 days to complete a response satisfying the FDA's queries.
3) The announcement yesterday from RAC did seem confident that the dialogue with the FDA, assuming it had made contact by phone and/or in person, made it clear that there were some remaining queries around how the clinical trial would take place. RAC seems confident these queries were logical to answer, to satisfy the FDA:
4) The 25/03 announcement of filing the IND, noted that "RAC are in advanced discussions around funding and completion of the paediatric trial". This is comforting.

So, now it is a waiting game. The trial was scheduled to begin in the second half of 2019. My best hope would be FDA approval around June/July? A Funding partner for the paediatric trial would be fantastic in the September quarter, following by commencement of trial towards December.

Thoughts?