Provention Bio

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anonymous said:
Very interesting therapy and opportunity, but a huge risk leaving a solid gig for this as a CRL is a very real possibility. Can't imagine they would keep any of the reps if that were to happen.

Thoughts? Salaries enough to entice you despite this?
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Looks like they had two rounds of hiring for sales reps. The current round is contingent on approval so there’s no risk unless you quit your current job before it’s approved. We should find out this week as Pdufa is 7/2…although many are expecting a delay because of manufacturing. They’ve built out an entire company and have been able to bring in many people with executive/director positions at good companies. 87 employees on LinkedIn and only 19 in sales positions. I’m not sure what they did to induce but I’m sure stock options were included which could be a fortune someday. Definitely a gamble but a gamble that many very successful people think is worth taking!
 




anonymous said:
Looks like they had two rounds of hiring for sales reps. The current round is contingent on approval so there’s no risk unless you quit your current job before it’s approved. We should find out this week as Pdufa is 7/2…although many are expecting a delay because of manufacturing. They’ve built out an entire company and have been able to bring in many people with executive/director positions at good companies. 87 employees on LinkedIn and only 19 in sales positions. I’m not sure what they did to induce but I’m sure stock options were included which could be a fortune someday. Definitely a gamble but a gamble that many very successful people think is worth taking!
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Thanks for the insight, most appreciated.
 




Anyone have any insight on what the fda is looking for with regards to PK data? Blood levels between the two drugs are different. They can’t change that. So what next?
 












anonymous said:
Anyone have any insight on what the fda is looking for with regards to PK data? Blood levels between the two drugs are different. They can’t change that. So what next?
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Please correct me if I’m way off here. I am not in the pharmaceutical industry. I do have T1D and I am very interested in this treatment for my children. The Bloodlevels for the new formulation only fall slightly under 80-125. This is based on a single dose in healthy people. The new pk data is from a 12 day infusion in pre diabetic children. After a 12 day infusion you would think that there would be some build up in the system to help the AUC fall within the window. This is my understanding.
 




anonymous said:
Please correct me if I’m way off here. I am not in the pharmaceutical industry. I do have T1D and I am very interested in this treatment for my children. The Bloodlevels for the new formulation only fall slightly under 80-125. This is based on a single dose in healthy people. The new pk data is from a 12 day infusion in pre diabetic children. After a 12 day infusion you would think that there would be some build up in the system to help the AUC fall within the window. This is my understanding.
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You’re correct. There are many questions that need answers before any approval is granted. Since the trial was done with drug manufactured over 10 years ago and the published results are based upon T1D prevention derived from that drug, the newly manufactured drug will need to be very, very similar with regard to AUC to be able to make efficacy claims.

I think the company feels confident in this but it clearly is not their decision to make.
 












anonymous said:
Big pharma managers, weak leaders who keep the VP happy by never challenging him. Reps are the same. One big circle jerk which was apparent in the interview process.
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Well, what a good analysis from afar. I’m not part of the “team” But, I am an Investor. Follow the Smarts; not the management. Good Luck! This is a good team, they haven’t been able to show it yet.
 




anonymous said:
Well, what a good analysis from afar. I’m not part of the “team” But, I am an Investor. Follow the Smarts; not the management. Good Luck! This is a good team, they haven’t been able to show it yet.
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I’d be concerned if I were an investor. The field team seems like decent people but woefully under qualified and rather unhappy.
 




anonymous said:
I’d be concerned if I were an investor. The field team seems like decent people but woefully under qualified and rather unhappy.
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I’m an investor too. In way too deep and wondering if I’ll ever see my money again. What do you mean by field team? Sales force? How are they spending their time while waiting for approval? They went on their hiring spree almost a year ago. Hopefully this company is prepared to get out of the gate fast with tep.
 
















anonymous said:
the type b meeting should’ve happened. Next step is the fda accepting the new BLA then approval decision within 6 months. Does that time line sound right?
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Could be accurate, but the timeline is in the agency’s hands. The bigger question is if you want to work for these people. Senior leadership is strong but VP of Sales on down is extremely weak.
 




















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