Chart, page-2242

Hi The Whale1,

Just thought I would clarify a couple things for you. We are technically already on a clinical hold as far as the regulator is concerned. Our IND can either be granted, on hold or partial on hold as per the FDA policies and procedures. It wont matter by end of Sept/early Oct (imo) as we will be open and on our way. The FDA would only potentially inactivate our IND application after 12 months without the sponsor responding as per FDA policies and procedures.

All we need is for the Divisional Director of the FDA's DAAP to sign off on our IND (Lift our hold) and we are away. I am confident that we will provide a detailed response to the last outstanding matter re the Rat non-clinical data and we will include a comprehensive mitigation strategy (clinical monitoring) in the protocol to get us on our way.

On the investor call Donna said “The best evidence in understanding whether something is clinically significant is to monitor something carefully during the clinical program. The discussion around the significance in the rat as well as the mitigation in the clinical program are the topic of what will be provided to the agency in the next 30 days”

I would not rule out a 3rd round but I think it is much less likely given this time around I think we will be focusing more on mitigation and clinical monitoring in the response and perhaps less about the discussion of how relevant the observations in the sensitive Rat are.

My views only. GLTAH

@The Whale1