RE:RE:RE:RE:RE:RE:RE:RE:My price is at least 1.70 CAD!!!Theodore50 wrote: Kristain7: Ok, I don't know where you get that the FDA Plant inspection will be done very soon??? This was on the Q2 CC, 2nd last Analyst questioned PL specifically on this, and his round-about answer was Dec +/- a few months. So that puts the FDA Plant inspection in the Nov to Feb timeframe, and FDA Approval into 2018 Jan or Feb likely, maybe even later. Therefore no PRV Voucher till next year either I am afraid. That's not really just a matter of a few weeks now is it!
Theo.
Rahul Sarugaser, Paradigm Capital Inc., Research Division –
Just to dig a little bit further into the BLA. So far as the BLA for plasminogen, has the FDA already undertaken their inspection of the manufacturing facilities? And if so, when did that happen?
Pierre Laurin, ProMetic Life Sciences Inc. - CEO, President and Non-Independent Yes, I mean there's back-and-forth, and we're scheduling in summer. That needs to be always scheduled very tightly with the FDA and the timing of GMP batches and the manufacturing and the campaign and so on. So I mean, this is in constant adjustment with the FDA availability and timing of those production batches.
Rahul Sarugaser, Paradigm Capital Inc., Research Division - Analyst of Healthcare and Biotechnology [41]
So if I understand you correctly, those reviews have not been completed in terms of the manufacturing?
Pierre Laurin, ProMetic Life Sciences Inc. - CEO, President and Non-Independent Director [42]
No, it has not taken place yet, no.
Rahul Sarugaser, Paradigm Capital Inc., Research Division - Analyst of Healthcare and Biotechnology [43]
And so then I'll project, based on you had originally projected Q3 for the BLA, so maybe November, December would be a more accurate function?
Pierre Laurin, ProMetic Life Sciences Inc. - CEO, President and Non-Independent Director [44]
That is still possible. Unfortunately, we cannot provide exact guidance really on the basis that discussions and opportunities to add more data on the clinical, if it makes sense, may become available to us. And I don't feel that's cleared. We do not want to commit yet to a firm date, plus, minus a few months. We know that we're ready to launch, and we also know that it would make sense to actually launch in Q1 to have all the logistics in place, as I mentioned during the call.
The inspection could take place in september as well as october. To pretend that it will be in november or december is pure speculation from the analyst from Paradigm Capital.