Back and forth we go

Back and forth we go

It seems like the FDA is having some issues approving insulin/GLP-1 combo products. After delaying the approval of Sanofi’s (NYSE: SNY) combo product, a move which appeared to give Novo Nordisk (NYSE: NVO) an edge as they too have a combo product in front of the FDA. Well the pendulum has swung back to Sanofi as they FDA has delayed the approval of the Novo combo.

According to company issued press release;

“Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for IDegLira, the fixed-ratio combination of insulin degludec and liraglutide in adults with type 2 diabetes.

The FDA informed Novo Nordisk that a three-month extension was required in order to complete its review of the new drug application (NDA) for IDegLira.

Novo Nordisk submitted the NDA to the FDA in September 2015, and with the extension of the review the action date is now expected in December 2016.”

The good news here is that unlike our wine drinking friends Novo didn’t blow $250 million to put their drug on the fast track approval process.

Diabetic Investor doesn’t believe this delay will hurt Novo all that much even if Sanofi gets to market first. Keep in mind this Sanofi we’re talking about, a company who has yet to successfully launch any diabetes drug that isn’t named Lantus. Now if Lilly (NYSE: LLY) was the competition we might feel differently as Lilly does know what they doing.

About the only thing in Sanofi’s favor is desperation, they REALLY need something, anything to go right in diabetes. Lantus is getting crushed and with Basaglar coming this stomping will only get worse. Toujeo has been a bust. Afrezza was a costly mistake and in typical Sanofi fashion of betting on the same losing horse not once but twice, they have put the person who was responsible for Afrezza as head of the company’s alliance with Google.

This is so damn Sanofi promote some guy who not only helped screw up Afrezza but also had the unique ability to also screw up the way cool and now very dead iBGStar. Not sure this is what our good buddy Serge had in mind when he stated he was looking for accountability. This like rewarding the captain of the Titanic, had he lived, with a brand new luxury liner. Perhaps Serge and his partner in crime Olivier felt that the guy deserved not just a second but third chance.

Maybe just maybe the third time around is the charm.

Now the other possibility is given all the beheadings at Sanofi the company had no other choice. That they were running out of bodies. Or perhaps no qualified management member, if there is such a thing at Sanofi, wanted the job. Perhaps they knew that high level management would only stand in the way. That no matter how well they attempted to do their job, Serge and Olivier would prevent them from getting the job done.

As Momma Kliff used to say; “At some point you have to open your eyes and acknowledge what everyone else sees so clearly. That you cannot continue to venture down the same misguided path that has only lead to disaster in the past. You can’t win by continually betting on the same losing horse.”