Update....

https://www.fiercepharma.com/pharma/amag-bails-proxy-fight-standoff-settlement-for-2-board-seats

 

well, well , well.... here it is October, the end of the year is fast approaching... what’s the over- under on when the lay offs begin to accommodate the new board structure?
I’ll start- I think it will be late November so the projections for 2020 can offer a better picture for the investors. After all, there will be 2 board members ousted in early 2020 so planning has to begin now. And once again, the entire sales team will suffer because of idiot corporate. Shocking.

 

Vyleesi is just starting to take off. They won’t do lay offs this soon into the launch

 

yep, corporate will want to work everyone into the ground for the remainder of the year and then wait for the 2019 financials before the lay off in February. Just like last year.

 

You know nothing!

 

Ok Einstein tell us your corporate lies. Go ahead.what’s happening?

 

I know as much as you, which is nothing. No one knows what the effect will be from the Caligan partners as well as the Makena investigation.

 

They will make a video that will go viral.
https://www.facebook.com/attn/videos/2451844068225066/?v=2451844068225066

 

Nice try. We are all in agreement that everything is going to hit the fan whether it is next month or 4 more months from now. We are also in agreement that the top management including the VP and Area Directors need to be replaced. Stop slicing at the RSD and field level where all of the real work is done.
Caligan has a chance to make it right, but doubtful that will happen. They are all just a bunch of investors that understand nothing about field level sales.

 

OH My god! Where did this come from

 

repost!!!

 

Makena investigation is inevitably leaving to cuts. One would hope the new board members would realize the mess that needs to be replaced at the top of R&D but seems unlikely.

 

This is the second post I have seen about a Makena investigation, but what investigation are you referring to? I am only aware of upcoming FDA advisory panel post PROLONG where FDA wants to revisit the approval of the sNDA given that PROLONG is not supportive of benefit. Have I missed something else?

 

"Caligan’s plea seemed prescient after AMAG was put on notice in late September that the FDA planned to review marketing approval for premature birth med Makena after a follow-up study found the drug wasn’t as effective as advertised.

Makena’s approval will face an FDA advisory committee Oct. 29 after a confirmatory trial showed the drug did not significantly reduce the risk of recurrent preterm birth or improve neonatal mortality over placebo. The review for Makena, which AMAG picked up in 2014 as part of a $675 million deal with Lumara Health, could be the first step in pulling the drug off the market.

Fadia said AMAG had yet to receive the advisory committee questions from the FDA.

On Tuesday, consumer advocate Public Citizen called on the FDA to pull Makena's approval, citing AMAG's confirmatory trial findings.

"The drug never should have been approved under accelerated approval in the first place because the data from the single phase 3 premarket trial that was relied on to establish efficacy were seriously flawed," the group said in a citizen's request.

Makena, initially developed by KV Pharmaceuticals, is no stranger to controversy. Prior to its accelerated approval by the FDA in 2011, the drug was sold for under $20 through compounding pharmacists, which also make the drug’s progesterone treatment competitors.

After approval—when compounding was no longer allowed by the FDA—KV listed Makena at $1,500 per injection. The public outrage that followed pushed the FDA to allow compounded competitors of the drug on the market to keep prices low. Makena was eventually sold off to Lumara after KV filed for Chapter 11 bankruptcy in 2012 following an unsuccessful suit against the FDA to block its rivals."

 

Everything points to another major shake up. Caligan will have 4 new board members and they are changing the voting rules on the bylaws. Oncology seems to be the only direction that Caligan wants to grow so everyone else is at risk.

 

The FDA and JD should track down all of the employees that were given the shaft back in February. I bet they would have plenty to tell concerning this Makena investigation. AMAG thought they were being clever in the separation packages but no signature on some papers can stop a JD investigation for marketing/sales improprieties.
No doubt that this is all about to hit the fan. I hope the so called sales and marketing “leaders” get jail time over this mess.

 

Most of the reps that were laid off in February were women’s health or Intrarosa reps

 

”most” does not = all. That makes it easier to track down the displaced maternal health employees. This will not just “go away”. AMAG is in it up to their eyeballs this time and they know it. J.Janssen, G.Ball, Heiden, Keisel, and all AED’s are in for a rude awakening.

 

Lock them up!!

 

Now that the Board has been infiltrated, the C-Suite and the VP-pool will be cleaned up. Who is first to go and who will follow?