With 5 Pd-1's or PD-L1's on the market, is this oncology position worth a look? I have a ok job in oncology but need to make a change.
BLA today?
Perhaps someone can explain the conflict of being told about a June 24th approval date but there is no PDUFA date for Regeneron or Sanofi on the FDA calendar for cemiplimab. No published documentation of NDA, BLA or PDUFA date. Starting to worry there is something amiss and I made a mistake taking this role.No BLA means they know there is going to be no approval. Check your history of other disasters
ETHICS.
I was told to prepare for a June or July launch. I don't see any FDA or corporate press releases to support this claim. I am fine with some time off. I am not fine if we get laid off due to failed launch planning and timing. Any REAL input is appreciated. You can leave the stupid crack pop comments off.There is no Advisory Committee date or PDUFA on the calendar. What were you guys promised in your interviews??
My suspicion is that they are holding the BLA completion because FDA has already expressed a concern about some of the information that has been submitted. Once they finalize submission, FDA is required to respond and that becomes public. No application, no FDA response required.
Probably trying to develop a plan B for additional data prior to the earnings call next month. People hired for the launch are the least concern leadership has right now. They are trying to protect the stock price from taking a 25% haircut. They can deal with employees after the earnings call.
Suggest you ask your manager what’s going on with the BLA.
Clearly something is wrong. What I have an issue with is that entire team sitting around and getting paid the highest salaries at the company. If it will be years then they need to be let go. Eylea is sick of paying for the rest of this crap company. Put them all on the asthma team and cut their bases. Why hire more?