I'm surprised no one has commented on what might be the gorilla in the room..
this is up for interpretation.
•Appointed Peggy Berry as Vice President of Regulatory Affairs. Ms. Berry has more than 25 years of experience in the pharmaceutical industry and began her career at the U.S. Food and Drug Administration. Ms. Berry has secured ten drug approvals during her career. She will be reporting to Will Lewis, President and Chief Executive Officer
Is this appointment out of fear that the information being provided to the FDA isn't as compelling as Lewis
had hoped? On one hand, I see the new facility, additional people, and other factors as being a tell that
management is reading this is going well. On the other hand, I wonder if maybe things aren't as clear to
a hesitant FDA to make these findings in our expedited favor, hence the need to bring in a big gun.
One would have thought someone of this capacity should have already been on staff. The need to have
this person now, does cause me to think out loud. I certainly hope, and expect to be wrong, and will take
this opportunity to add more shares if we do touch down below 17...
I believe this was in the works for several months. Piper reiterated at $45. And I think that they know more than most. The Doctors involved with NTM and the NIH should prove helpful, if not this month, certainly this year.
◾Characterize formulations using appropriate analytical techniques, such as, but not limited to HPLC, optical and fluorescent spectroscopy, particle size assessment, zeta potential, microscopy and other
◾Perform calibration and maintenance of the laboratory equipment
It takes between 3 to 6 months to begin the recruiting process for someone like this, interview all of the prospects and eventually make offers. Then negotiations on salary and stock compensation and, finally, a hire. This appointment was a very long time in the making, coinciding with a desire for expedited and concurrent multi-use approvals.
bulhockey! You think a company with a drug with results from last July would now all of a sudden hire someone? Now you people get to worry about where or if NTM has a filing because we already know Insmed dropped US plans for CF.
Zake, if we are pursuing approval for both CF and NTM in Europe and Canada first, is the FDA involved in that? Or does this appointment indicate we are going to try and get approval in the USA? Food for thought either way.