Ann: PARADIGM PROVIDES IND APPLICATION UPDATE, page-57

As others have pointed out, it appears the IND application contained too much data/information to be adequately considered within the 30-day review period. In particular, the culprit appears to be newly submitted non-clinical data. To give an indication of what this data may be, I took a screenshot of the following statement from the announcement released to the market on 26th of March:

While there are some potential stumbling blocks, I remain positive the delay will take much less than 60 days.

It appears the FDA simply requires more time to compile their questions and to ensure the new data is consistent with the proposed clinical program. I don’t think there will be any safety issues or inconsistencies with the new non-clinical data and the clinical trial program since: 1) this would be market moving and the data has not been released to the market and 2) the FDA did not allude to a possible clinical hold or suggest any modifications to be made to the trial, which they would’ve signaled during the call.

Although this appears to be just a minor delay, there may still be an opportunity to top up in the 2.20 range. I certainly will be looking to top up if the SP falls further.

GLTAH