We need to stop complaining about what we don’t
Post# of 155150
(Total Views: 682)
Posted On: 04/16/2020 8:37:31 AM
Re: Investor91 #28007
We need to stop complaining about what we don’t control and get done what we can.
The reason big pharma passes us is because they have more people and more money to get tasks done in many cases with internal and not external people who have other customers competing for their time.
Case in point we learned last September that we needed stability data for cmc section submission - first of all we already should know that if this wasn’t our first submission since you always need stability data in your final container format to get shelf life dating. That data timepoint was available in late December and to this day that section has not been submitted pretty much negating any advantage to rolling review. We will hear that we are busy on other things or we were waiting for higher stock prices before raising money - all good reasons but not still not the FDA or governments fault and not a problem bigger or better funded companies have - they have scores of people and plenty of cash to do this work.
We are doing the best we can with a too small internal team and reliance on more expensive external partners that have competing priorities from other companies.
Everyone needs stability data on their product and we won’t get approved for regular indications until we submit it.
I am very long and want success as much as everyone else but the constantly blaming others is getting old.
We need to realize our situation - we seem to have a great compound and will develop it as we get funds - see GVHD,, Nash etc
All IMO
The reason big pharma passes us is because they have more people and more money to get tasks done in many cases with internal and not external people who have other customers competing for their time.
Case in point we learned last September that we needed stability data for cmc section submission - first of all we already should know that if this wasn’t our first submission since you always need stability data in your final container format to get shelf life dating. That data timepoint was available in late December and to this day that section has not been submitted pretty much negating any advantage to rolling review. We will hear that we are busy on other things or we were waiting for higher stock prices before raising money - all good reasons but not still not the FDA or governments fault and not a problem bigger or better funded companies have - they have scores of people and plenty of cash to do this work.
We are doing the best we can with a too small internal team and reliance on more expensive external partners that have competing priorities from other companies.
Everyone needs stability data on their product and we won’t get approved for regular indications until we submit it.
I am very long and want success as much as everyone else but the constantly blaming others is getting old.
We need to realize our situation - we seem to have a great compound and will develop it as we get funds - see GVHD,, Nash etc
All IMO
(7)
(0)