Anyone else feeling like Management are focusing on the wrong end of product development?
you have a product that has a FDA CRL that needs addressing before approval... company hasn’t even acknowledged the receipt of such a letter, let alone given any explanation or detail of what is being questioned. Almost two years... nothing. And the thing they said could be done very quickly ... for a few million... in a handful of months... that was supposedly ready to go... now why have management not pulled the trigger on that?
im going to hazard a guess what has happened with Vivagel... looking at how the FDA handled MSB’a BLA for Ryoncil- I believe the FDA required all Vivagel data to be considered before approval.. including the failed trial data.
you also have phase 2 trials which are quite small.. and yet take years to recruit... why? When the phase 2 trial is said to be almost complete... it is extended, more patients required... why? Did management not get the outcome they wanted and suggest to the investigator that we should expand the trial to try get a more consistent outcome .. or anything that a pharma may want to partner with?
ive been waiting for almost a couple years now to buy back in... I still haven’t seen anything to sway be to be a holder again. The opportunity cost of holding this stock is going to be huge.. so much happening outside of SPL! Nasal spray is going to be like hand sanitizers... easily saturated and the big pharmas will get it to market so much quicker than Snail Pace Limited.
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