Ready to launch HTX-011?

Fairly certain the mfg comment is written by an outside troll.

 

None of you have a clue what's about to happen. I'd have your affairs in order. Remember sustol? Since then things at the office and in my team have actually gotten worse. You would think we would have learned. I don't expect my manager to be around in 2020.

 

I will eat you

 

Would not be surprised at all if idiots at Heron screw up filing or have some CMC issue. Mostly B and C players at this company and I bet the same dopes that screwed up Sustol are still there.

 

Well there it is AGAIN. This company has the WORST manufacturing, quality, reg cmc people in the industry. It’s embarrassing for the rest of the staff that did their jobs. Why can’t we hire some professionals that know what they’re doing? People need to be fired or demoted to right this ship.

 

JA and LT

 

Can't fault Heron. They'll recover from this. Looking from the outside in, it seems like Heron is lined up to sell. I bet it will happen without approval.

 

Very sad news. How long can the delay be? 2 months? 3 months? 6 months? They will probably lose good people if not resolved right away. Yes it is a contingent offer, but there are other opportunities out there and not always wise to hang your hat on a one product company.

 

They should be able to resubmit and hopefully get it resolved in 6 months. If they want more data 12-18 months before they hit the market. Most people just want be able to wait that long.

 

I agree. It will be a minimum of 6 months and that is just too long for someone to wait. Too bad for Heron. If it is a very long wait, they will not be able to retain the hired managers and that is unfortunate. The managers had to take the risk and many quit other jobs to take this job. This industry is very cruel. The idea of a contingent offer is good, but there are always some that still take a dive. If they are still confident they will get approval, they need more investor money to drive up the $ shares in stock. They need to hire and allow time to prep the market and establish relationships in all the territories before thinking about launching. To hire people and expect them to train very quickly and launch immediately just doesn't work in this climate anymore. People need that time to begin building up a database and POA before jumping into the pool.

 

what gives you all confidence that it will take at least 6 months to get this fixed? I'm a reporter who is interested in writing about this--I'd love to talk to anyone with knowledge of the situation. shoot me an email at mpulsford[at]thecapitolforum[dot]com.

 

Go away troll. Even if you were legit, no one is going to do your job for you. Such a pathetic post!

 

Miles you're pathetic.

 

Minimum 6 months. Heading into summer so BEST case is we're looking at 90 days from today resubmission. (30 days to request the meeting, 30 days to schedule, 30 days to the minutes. Keep in mind this is GUIDANCE and not written in stone). Once we resubmit we'll be notified if it is a 4 or 6 month review.

Once we get the minutes, we need to resubmit, the CMC submission needs to be reviewed and an inspection needs to be scheduled, prior to FINAL review. Best case is we're looking at early 2020, Likely mid Q1

 

Second time is always an approval! Mark my words!



Sincerely,
Recro

 

It's a full blown party in Parsippany after your CRL. Gleeful may be a better way to describe it. But it's just a delay.
EXPAREL missed on its NB approval, was approved a couple months later. Same will happen with HTX. FDA didn't ask for additional studies, that would've been the killer.
Pacira should be an easy target. No leadership. Zero National Contracts. Horrific culture. Don't screw this up!

 

Excellent post.
Hopefully accelerated timeline. But yours is likely realistic.

 

The FDA’s processes should be reworked. Good god... From what I hear we have more or less everything they need........

The agency is disgusting

 

Everything except a FDA certified manufacturing facility. Sloppy drug production = patient safety.