Ann: Trading Halt, page-216

Potential Announcement tomorrow. My views only. How close will this be? Perhaps I will be wrong and it is a solid Green Light. Perhaps we will be on a Partial Clinical Hold with questions still to answer and we can start part of the protocol. But I think this would be unlikely and impractical anyway.

Here is my guess at the pending announcement. Dont get offended. Just my gut feel.


Paradigm previously reported that on July 30th the company received feedback from the FDA regarding the IND application for its pivotal Phase 3 trial. The company and its regulatory consultants have now reviewed the feedback.

The FDA has advised that it has an outstanding query concerning non-clinical toxicology data submitted in the IND application. The toxicology data was requested by the FDA at the time of the Pre-IND meeting in 2020. Paradigm expects to submit a response to the outstanding query no later than August 16th.

Once the company submits its response the FDA will have 30 days to respond.In the event the FDA responds with additional queries at the conclusion of the next review period Paradigm has the option to request a Type C meeting to clarify any outstanding issues.

Whilst the company does not believe the outstanding issues represent a lengthy delay to its USA Phase three trial the company will immediately commence clinical trials in Europe and expects first dosing of subjects in Q4 2021.