I hope our jobs are not in jeopardy due to the delay. My guess for a best case scenario 812 launch September 2021. A more realistic time frame to sit with FDA get the answers needed to regroup and submit a clean NDA 18-24 months.
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Unimaginable
- Thread starter anonymous
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Everything is going according to plan. We will launch right before the school year starts which was always our intent. In addition we avoid launching during a pandemic. Anyone that believes this wasnt a self inflicted wound is crazy.
If I have to sell TXR OXR until September, I’m going to slit my wrists.
Anyone who believes the company would deliberately sabotage our own launch after we’ve already been in these offices hinting at a new drug coming “soon” is delusional. This was a huge misstep. It will cost us months, if not a year, in launching this product.
Deja vu, anyone? Migraine launch, perhaps?
Maybe corporate needs to rethink the team writing these NDAs. Second major fail. (That we reps know of .... hmmm)
we would be better served by rethinking the reps who can’t penetrate more than four percent of the topiramate market.
I forget how your rep experience qualifies you to know how the FDA works.
In the case of migraine, that could have gone either way up until the end depending on how the pediatric patients were viewed. Next time we will be sure to consult with you since your after action analysis seems to be so prescient
different poster... so could spn812 have gone either way until the end too? Because they called it pretty much a slam dunk. How were these “minor” issues so unforeseeable? The constant issues here seem to be false expectations and consistently treating the field like we are children who know nothing and giving us ridiculous busy work to do while we wait around for the next “life changing moment of our careers”
This will just be another thing we have to explain in our offices.
The serpent with two tongues. You estimate market penetration to be at the most 5%, the reps deliver near that, despite significant market volatility with introduction of CGRPs (which you time and time again said posed NO threat to our market, and refused to address within the sales force until the extremely unsuccessful anti-cgrp campaign - hope someone got fired over that debacle) then you criticize them for not getting more? We had the “most successful launch of any AED in the last decade”.... but maybe you don’t remember that marketing moment?
We were never expected to be a powerhouse based off of TXR or OXR. They were merely supposed to be our foothold in the door. We had a better than expected run with TXR, and lingering continued support for OXR. The rapidly dwindling number of scripts for TXR and our history of patients failing to get refills after 3-6 months should show you what our manufactured data and post hoc pragmatic assessment fail to - if it made that much of a difference, people would stay on it. Get real.
What happens to the contract reps that were going to start at the end of the month? Any word?
They are gone. Best case sec stop they can hope for a delayed start date.
If you were looking for a sign / excuse to explore your options. This is it.
I really do feel bad for them. The CSO people. They have been on the stringer for a long time.
Do we have any more assets in the pipe? Just doing some simple math on my ginger tea napkin and it’s not looking good. Is 812 under a FDA level 1 or 2 review?
FDA lab issue sounds like a level 2.
FDA lab issue sounds like a level 2.
All those months that were spent sitting on our NDA packet “preparing” to file and you couldn’t even get the damn address right.
Wrong address for a lab? Pick a date to launch sometime between 2022/2024. To be fair it may be sooner with much less data. I can’t see the FDA letting us use any data from an unauthorized lab facility. Just imagine 2 day rides with your RD with no data.