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anonymous said:
Yes and the approval for GERD is pretty much guaranteed. The only thing stopping it was needing time to examine the shelf life which they have.
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Two pending CRLs examining nitrosamine contamination…which has been a sensitive issue in the medical community lately. Far from a guarantee the fda gives the green light, as if there is such thing as a guarantee. we’ve hired a salesforce only to let them go due to regulatory failures multiple times already. Not trying to be overly negative but always good to not let your guard down in this market..
 




anonymous said:
Two pending CRLs examining nitrosamine contamination…which has been a sensitive issue in the medical community lately. Far from a guarantee the fda gives the green light, as if there is such thing as a guarantee. we’ve hired a salesforce only to let them go due to regulatory failures multiple times already. Not trying to be overly negative but always good to not let your guard down in this market..
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ARS is a Prime example, they had a “guarantee “ for nasal epinephrine. Look what happened.
 








anonymous said:
Two pending CRLs examining nitrosamine contamination…which has been a sensitive issue in the medical community lately. Far from a guarantee the fda gives the green light, as if there is such thing as a guarantee. we’ve hired a salesforce only to let them go due to regulatory failures multiple times already. Not trying to be overly negative but always good to not let your guard down in this market..
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Sage also blindsided, hired full staff and people quit good jobs and BOOM, no MDD indication no more job. This place is High Risk too. Be Aware!
 








A friend was hired in a contract role to launch a new pain medication. The drug was a generic opioid but with a new extended release coating.

The company hired about 300 reps. They had new laptops, iPhones, national launch meeting at Disney World.

They never could get any significant formulary coverage and 10 months later, everyone was laid off.

If the company is a one trick pony, i.e. a single drug, there's significant risk with regulatory approvals. They're farming out production, packaging, so it's a tenuous licensing start-up. Definitely a high risk but high reward proposition if it all comes together.

Look before you leap, especially if you've got a family to support. Hope it all comes together and works out for everyone.
 




anonymous said:
A friend was hired in a contract role to launch a new pain medication. The drug was a generic opioid but with a new extended release coating.

The company hired about 300 reps. They had new laptops, iPhones, national launch meeting at Disney World.

They never could get any significant formulary coverage and 10 months later, everyone was laid off.

If the company is a one trick pony, i.e. a single drug, there's significant risk with regulatory approvals. They're farming out production, packaging, so it's a tenuous licensing start-up. Definitely a high risk but high reward proposition if it all comes together.

Look before you leap, especially if you've got a family to support. Hope it all comes together and works out for everyone.
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DOUBLE DIP IS THE BEST WAY TO GO IN THIS SCENARIO!
 
























































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