Oncology Position

We were told we would be in the field selling in May. We will hear an update in a few days. Why are all of you so negative? We have fast track designation. This means break through therapy.

 

Even with fast track designation, a BLA has to be completed and submitted. Investors were told it would be done in Q1. The EMA filing was completed in early April. Missing timelines is not good business.

There is an unmet need..

 

Well maybe not. $314.25/shr, hasn't closed there since the summer of '14. But don't be nervous, the leadership team has got this and they are extremely trustworthy.

 

New 52 wk low right before closing, buy, buy, or bye, bye?

 

Please look at how prevalent this indication is. It is very rare the larger opportunities in the PD-1 market place are owned by Merk and BMS and have been for years. It is kinda like selling the 5th statin, or allergy Med. Yes a different indication but it’s growth potential outside of this extremely nich market is very very limited. Do not leave a good job to go to this.

 

1/3 of accepted breakthrough status drugs are ultimately approved....that’s why you accept job contingent upon approval

 

Exacty. There could be a safety signal that requires additional studies and/or it will just not ever be approved. I would never take a job that didn’t have a complete BLA submitted with a PDUFA date. What were those reps thinking?

 

FDA has previously acknowledged that the term “breakthrough” is somewhat misleading.

It means there is a high unmet need and the product designated as breakthrough has “potential” to advance the care of patients, IF it actually works the way it is supposed to work and is safe, that is an appropriate risk/benefit ratio.

Breakthrough status does not replace the need for a completed BLA or NDA and FDA approval.

PDUFA date is only granted after BLA submission is complete.

 

Will someone please post the website for BLA submissions so I can see for myself?? Thanks in advance.

 

you are wrong on definition of breakthrough, fast track is for unmet need, generally breakthrough occurs 7-8 months faster IN TOTAL TIME than “regular” approval. We will get approval it just may take some additional time. Worst case we go buy another drug or partner or get assigned to another drug in our portfolio. Company is on solid financial footing, no worries.

 

if the BLA is submitted tomorrow, the earliest you could expect approval is 2nd week of July, and it could just as easily be after Labor Day.

 

so July or August or whenever it is...it is

 

Relax. Meeting with FDA Thursday. Will know more from that.

 

that sounds a bit ominous, if the BLA was already completed this meeting could be some label negotiations, but since it’s not, this sounds more like FDA concerns with the information to date.

 

The more longer it takes, the more likely to lose the niche market to pembro or nivo. If they happens, it’s over.

 

so it will be niche/2

 

Ok math wizard. Add this to your equation

Pembro + Permanent J code > any product + misc J code.

You do know what a j code is don’t you?

No oncologist will choose a product with a miscellaneous J code over one with a permanent J code if the efficacy and safety data are even close, especially when they have years of first-hand experience with one of the two products.

 

Pembro and Nivo each launched with a Misc J Code too. This will have NVCN guidelines, at least until 2019-2020. Always the pessimists. It’s just a hurdle to work through. Done it before.

 

Doesn’t matter about j codes boys and girls, it does not appear that the final BLA submission is going to happen anytime soon.

Suggest you pursue dupixent job in your neighborhood before it’s too late.