Forgot one set of paragraphs in that post, kinda an important one...
SPEED UP
Don't feel bad and frustrated that these time lines are long....things can play out differently too!
Our data may come out to be good enough to make the FDA more open to the idea of a faster pathway.
Example...maybe our trial gets opened and though we still have to continue the P3, we might get a provisional licencing approval of sorts.Another way forward might be expediated pathways...there is even a small chance (I don't rate it in my calcs BUT its not impossible) that we don't even have to do a Third Phase! Unlikely....but as I said not impossible.
SLOW DOWN
I'd much rather contemplate the Speed up scenario but we have to also weigh and factor this in too...there is a chance things will take longer than anticipated even if our data ain't bad. I'm enthused as we are dealing with an official Orphan indication here, that usually means quicker not slower.
ONE LAST POINT
Again, pathways and timelines are unknown...we don't know what might crop up...BUT a deal is a deal...we get a meaningful distributional type partnership at any stage of the MPS program and it will make a noticeable positive impact to our share price. It will also add wonders not only directly but indirectly. We will become so much more of a legit company that has a proven drug AND a proven relationship. A different game we will be in.
My thoughts.
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