It was a good read of the article you made reference to GG. to get a better understanding of the IND process, there is a fair bit involved but at the same time I believe we are in a good position...
- PPS has been in the market (albeit different physical format) for 60 + years
- We've already passed Phase II and many examples now (with aid of SAS program) with human cases.
- We have staff that have experience with dealing with FDA
- Our manufacturing process has been formulated (again, for X no of years), we have the batches ready to go.
- Our CEO, and other senior management have a wealth of experience in this area and with submissions to the FDA themselves.
- Primarily our drug works and is safe and is meeting a very large unmet need.
The next phase will be interesting but I dare say we will need some amount of patience specially when us investors wont have much if any feedback on how its all going...Maybe I should shut my internet connection down for the next few months and not look at the SP?
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