Approval Updates:

Well ......... Anybody seeing or hearing anything? This Friday is the big day. Any advanced indications good or bad from Iroko Management or CDER? Any concerns going into this week?

 

Hmmm....from what I gather everything is still going as scheduled and will know the 18th or 21st for approval. But the FDA is still reviewing all PDUFAs as scheduled so the big day will be at the latest next Monday.

My worry originally was the shutdown, but this statement from FDA puts that to rest that they are still reviewing drug approvals because that activity is supported by the fees pharma pay them.

http://www.fda.gov/ForIndustry/ucm370652.htm

 

Yeah - thisis accurate. Seems really stupid to get worked up at all about the government "ShutDown" Anyone with a brain knows the government is really incapable of getting anything done - therefore, a "Shutdown" of those inane activities is really a mute point. Excluding the armed forces of course -- we appreciate their service ! And just as an additional thought ...... Do we really? Do we really appreciate their service????
Me thinks no!!
We don't, it's just become the mandatory expression when the military is mentioned. Like facing forward in an elavator. Baaaaa - Baaaaaa good sheep!

 

Just shut up - turn around and close the elavator door LeRoy

 

Is anyone worried the drug won't get approved? I don't see why it would not being it is a new formulation from an existing product.

 

You're right of course! Everything the FDA does or doesn't do makes perfect sense.

 

Zorvolex has been approved...

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved ZORVOLEX TM (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults1. ZORVOLEX was approved at dosage strengths that are 20 percent lower than currently available diclofenac products. FDA approval of ZORVOLEX was supported by data from a Phase 3 multi-center, randomized study in which patients treated with ZORVOLEX reported significant pain relief compared with patients receiving placebo2.

 

EXPENSOLEX!

Excited with the news but OMG I just heard buzz on the price...I hope marketing has a co-pay card and a great vis aid! And mco access!

 

Good luck with the managed care

 

Re: EXPENSOLEX!

What price have you heard

 

Re: EXPENSOLEX!

If you've heard a price, please share it and the source of your news. Of course this drug will be branded, not generic so it will cost more than everything out there but Celebrex and Flector Patch. Still doctors write those 2 products like crazy. That patch is $1.60 per.

The real adavantage of this product is reduced hospitilizations. Take a look at how many people go to the ER for GI Bleeds every year. This drug will save money in the big picture. I think health plans will embrace this drug. But remember, it takes time to get on a health plan. We will have to lay the ground work and be patient at first but the sales WILL come!

 

Re: EXPENSOLEX!

 

Low dose Lodine with a box warning and more expensive than generic.

Good luck schmucks!

 

Re: EXPENSOLEX!

the groundwork you are going to lay with this drug won't pass inspection to get on a health plan if it is only for acute pain... even if it ever got a chronic indication it is another repackage that will ultimately fail in todays health care environment or obamacare cost cutting strategies that are coming into place

 

Just like with Endo & Voltaren Gel not covered by state plans/largest plan in state & 1/2 sales force gone 1 year later! Enjoy your year with so many reps.

 

Just remember Iroko is just a contract and NOT a true direct hire company position.

 

Hey thanks for this bit of insight. You're the type of mental catalyst who might just bring on the next enlightenment ! I suppose what you are stumbling to say is we are all at risk and if things don't go well we could be let go? Right? Gosh Beaves - Is that a whole lot different than what could happen if you and Wally were hired as a direct hire? You really believe that nonsense? If so - Let's talk soon. I have a few pieces of buried treasure I would like to raise some capital to dig up and I think you might be my Huckleberry

 

Chandler must really have been tired of Cephalon to buy into this deal...

 

Iroko DM here: the approval was expected, but the label isn't what we hoped for. similarly, we hoped to hire certain reps, but didn't get the $ we wanted, so we had to lowball the offers.

Can you say "me too" product??

 

Prove you are a DM. Judging by the other posts you made within minutes of this one like penis sword fights in a hotel room with a room mate I doubt it and hope not. More like someone who didn't get an offer!