Ann: IND QUESTIONS RECEIVED FROM US FDA, page-11

Looks good to me. PAR has essentially stated that they will be following the guidance received from the FDA:

"The agency also provided its suggested mitigation strategies to address its positions and questions, which included further detailed clinical monitoring"

"Paradigm's responses to the FDA questions will include mitigation strategies consistent with the FDA's suggestions"

My biggest concern was PAR would have to complete further studies prior to starting PAR_002. Now it seems there only needs to be greater oversight, resulting in recruitment into PAR_002 to be delayed until August. This time delay has already been priced in to the SP, but we might see a slight dip in the SP and sideways movement for the next 2 months, so take care.

PAR also stated there may not be any major delays to the completion of the pivotal study, so i wouldn't worry too much:

"Additional sites may be added in order to ensure completion of this pivotal study, within the planned commercialisation timelines"

So overall it seems there is nothing structurally wrong with the IND so it should be good to go once the FDA responds.

GLTAH