General discussion, page-3692

The feeling gets better and better that's for sure ...

Expedited pre-IND submission progress update can't be too far off - happy sitting tight on the wait-
plenty to be prepared and to ensure all the i's dotted and T's crossed - that's what this team (IHL)ensures no matter what level of detail it needs to bring to the table....

Preparation is critical to each requirement of the process flow for the submission to receive approval and reduce potential time to market .....

Camargoand IHL addressing the requirements of the pre IND both separately and together to ensure an effective / comprehensive submission -
( win win as IHL gain the knowledge of the process and what will be required in future further applications which will no doubt be forth coming imo)



FDA
sure seems simple enough... but then match it to the FDA 'checklist' for process and required information...






and then bring it altogether into the pre-ind meeting packet...



then review to ensure there are no omissions or compliance deficits ...most likely through simulating / end gaming the process to ensure the packet is correct and comprehensive ...


conduct final packet review


Considering the Christmas vacation period and the ongoing fluidity of the Covid19 restrictions as they apply and change, on what seems a daily basis, slight delays are to be expected in the preparation and submission process imo, what makes it easier is knowing that this will allow the market to fully appraise and realise the potential added value proposition being leveraged through this pre IND process (and what I assume will be a successful outcome) just in this single instance of the stream of life changing medications this company is researching and developing .....amazing!

...meantime loving the SP play action - so much to look forward to being a shareholder in this cutting edge, innovative, forward thinking biotech company -

As always happy to be corrected - good luck all