Response from FredSorry for the delay. I am as you can easily imagined overloaded with emails from fairly large number of shareholders. I try to get back as quickly as possible to all but may end up missing a few along the way.
how PLI is progressing with the FDA like are we meeting with them:
We have met with them a few times over the last few months as you know and both for PBI-4050 (ALSTROM SYNDROME PIVOTAL PHASE 3) and for the plasminogen BLA process (Type C meeting we announced last year. We continue to interact with them in our preparation to submit amendments to the BLA. We have a good relationship with the agency.
are we on schedule with the timeline set.
As Bruce mentioned during the Q3 call, we are doing our best to stick with the disclosed timelines. We’re still looking at filing the necessary documents for the BLA around the mid-year mark with an end of 2019 timeline for the response from the agency.
Are we producing any product,
The Laval plasma purification facility is entirely focused at the moment on the work necessary to advance as quickly as possible the ongoing plasminogen BLA process
any recent conventions attended and how did it go
Great week last week at JP Morgan where we ran 3 tracks of meetings per day (Business development with potential pharma partners, investors, bankers, analysts etc…). The conference went very well, very well attended by top names and we can see interest for both PBI-4050 and plasminogen. As good as these conference always go, the trick is to be successful in following up and transforming all this great interest into actual deliverables and live action with concrete results. We also regularly present at scientific conferences where our scientists generate a lot of interest with our results. For example, Dr Lyne Gagnon recently presented at a NASH conference in front of hundreds of scientists and industry people…
etc. I emailed Mr Best but no response. Should I be worried by the silence? Your thoughts.
No, please don’t read too much into the delays in getting back to you, as mentioned, we are overloaded with emails, calls and request for info. We do our very best to get back to everyone but it can be a little overwhelming at times…
Hope this helps
Best
Fred