What is going on with Depomed?

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Depomed To File NDA For Serada For Treatment Of Menopausal Hot Flashes


(RTTNews.com) - Depomed Inc. (DEPO) announced that it has completed a Type B pre-NDA meeting with the United States Food and Drug Administration regarding the results of the three Phase 3 clinical trials of Serada (extended-release gabapentin tablets), Depomed's investigational gastric-retentive, extended-release formulation of gabapentin for menopausal hot flashes.

Based on the results of the meeting with the FDA, Depomed said it intends to prepare and file a new drug application with the FDA in the second half of 2012.

In October 2011, Depomed announced the results of the BREEZE 3 clinical trial of Serada and also announced at that time its intention to meet with the FDA to discuss possible pathways to filing a new drug application or NDA in light of the results of the three Phase 3 trials of Serada completed by Depomed.

Efficacy data from the BREEZE 3 trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks, the company said.

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Run, Run, Run away! I worry about this company. A large number of reps have left, been pushed out or left before the PIP hit the fan. Current product has small indication with management leaning on reps for "selling pain". Saw that they have MSL opening in Midwest, but I would not touch that either.
 






Anonymous said:
Run, Run, Run away! I worry about this company. A large number of reps have left, been pushed out or left before the PIP hit the fan. Current product has small indication with management leaning on reps for "selling pain". Saw that they have MSL opening in Midwest, but I would not touch that either.
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I could not agree more. Those 5% of the reps leaving is alarming. This company is in such bad shape that the experts all have a buy on it. These guys expect us to sell 10 scripts a week after the 6 month launch. The nerve to ask specialty reps to sell a pain product to Pain Management providers is unheard of in this industry. After all the are the easiest to move marketshare with. I'm sure you are the perfect person to be the MSL. That direct hire thing later this year is a horrible thing. I'm like you and miss my pod mates so much.
 






Anonymous said:
Run, Run, Run away! I worry about this company. A large number of reps have left, been pushed out or left before the PIP hit the fan. Current product has small indication with management leaning on reps for "selling pain". Saw that they have MSL opening in Midwest, but I would not touch that either.
Click to expand...

You are an idiot. Wow, do you actually have to work? I am going to guess you do not even work for the company. At any company, management makes a huge difference. And, the MSL took an opportunity that required less travel.
 






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