Approval risk for HTX-011?

There is virtually no information/data on HTX-011 in the public domain that isn't directly sourced from the Heron itself. Kind of odd for a drug at this late stage in development.

Interesting take on HTX-011 that recently surfaced:

https://avanospainmanagement.com/wp-content/uploads/2019/03/HTX-011-Hope-or-Hype-Hostetter.pdf

Obviously have to be cautious when interpreting the opinions of anyone who may have a conflict of interest or predetermined bias -- no doubt about that. And with this author, it is no secret that she is being compensated by a company who is selling a product that HTX-011 would compete with, if approved. But given the lack of comprehensive information on the drug, particularly from sources outside of Heron itself, I find it hard to push back on some of the questions/concerns she raises. If there was peer-reviewed literature available on the HTX-011 clinical trials, perhaps some of these questions/concerns could be easily put to bed. But there aren't, so the only defense we'll probably see will come from Heron.

Putting blind trust in information that comes from a single-source is a potentially dangerous game. But the FDA is likely to leave no stone un-turned in their review of the drug's application (at least, we hope). Begs the question: is there significant risk in an approval for HTX-011?

 

Ruh roh

 

These are legitimate concerns. The pain market is a tough one in an ever growing crowded market. Great to see many current non-opioid choices and there are many more on the horizon. It won't be an easy sell, but again nice to see more options. If it is priced too high, pharmacy will rip it to shreds.

 

Risk is the name of the game

 

Let's see how well Mike Mathews and his dream team of Cadence f**ktards handle this. One thing for sure is if things don't go well they will blame everyone in the company except themselves.

 

Significantly different product. Anyway— proof will be in the pudding

 

experal goes generic 2 years.
Experal price reduction coming immediately after this product is approved.
This will sell for sure but it will be tough.
I’d take the risk because it is a better therapy but the financial reward meaning a bonus may not come along with the deal.

 

OMG will you go away? THEY DON'T WANT YOU! Get that through your ape thick-like skull. Yes, we all know you want the job. You're not getting it. So stop being such a disgruntled baby and move on.

 

Exparel doesn’t go generic in two years — it may never actually. Do your homework before making claims like this. No company has even filed to the FDA for approval of a generic Exparel to challenge the short dated patents. The liposomes make it just too hard if a drug for generic companies to manufacture. So patents or not, the drug will be around for a long time. You can make your own assumptions around if there will be price reductions once Heron’s drug starts selling (if approved, that is).

 

I agree look it up and when you do let ys know but to say it doesn’t expire is not correct All products have patent life and they expire. Exparel is not special. The question with any expiration Is can the molecule be duplicated and at a cost that makes the generic money. Once a generic files you will know. Still plenty of time for them to file. Pacira believes it can’t be duplicated. Koolaid or concrete?