CC TRANSCRIPT -- Q3 2016, Seeking Alpha: seekingalpha.com
Extract (edited to comply with Seeking Alpha 400-word restriction) ——
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"It's actually amazing what is being achieved with the budget that we have.
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If you move to Slide 8, IVIG, well, I mean in the quarter we complete the enrollment of the adult patients to course. So, we expect to complete the trail from the same period next year and filed the BLA shortly thereafter. So that's our second plasma-derived product expected to be approved as to plasminogen. And as I said in opening statements, IVIG alone is expected to generate over $200 million a year. So, I think it's pretty exciting time guys, two frontrunner products really driving revenue and near-term catalyst for the Company.
So moving onto PBI-4050, well, again this one doesn’t disappoint. The PBI-4050 met primary and secondary end points for most of use of -- not a surprised, but obviously good to have confirmed. Very important for us again, the study has helped us fine-tune our clinical program. You will hear more about it during the Analyst Day where we do a deep dive on both plasminogen and PBI-4050. But I mean it's clear that this trial served its purpose many time over. I mean we have demonstration of translation of pharmacologic activity from preclinical to humans, it is very reassuring that the performance on the preclinical model predicted perfectly, how it behaves in humans, the dose level was chosen, everything work.
And we have many-many factors to look into and reassurance out that the drug is doing what we expected to do, both on the fat tissue, on the liver, on the pancreas, the drop of the biomarkers were associated with cardiovascular events and these are bonuses. I mean this is amazing. These biomarkers are really signaling that the patients have their kidney or heart stress, and those patients are at high risk, much higher risks than the general population to develop a myocardial infarction or kidney injury. And the fact that PBI-4050 reduced, those signals those stress signals is very-very significant. So look forward to further update at the Analyst Day."
Jim |
