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Biotech / Medical : ProMetic Life Sciences

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Cush

To: Cush who wrote (159)	12/20/2017 1:28:57 PM
From: axial	1 Recommendation of 250

Followup — No content changed. Edited for clarity. A few questions on latest PR. 1) Of IPF population, how many will experience AE-IPF ( %): — Excellent question. Some studies refer to approximately 15 % of IPF patients will experience acute exacerbation episodes within a year of diagnosis while other studies refer to as much as 20% will experience within 3 years. It is significant enough to represent an unmet medical need. ____________________________________________ 2) In previous mail to SH you mention: "This is indeed new info for the public. We have been waiting for a while for the orphan drug designation and finally received it. When was the designation asked for? Couple of months ago…." Do you have a trial protocol established as J. Moran clearly states your intent to trial PG on AE-IPF? — Working on it as we speak ____________________________________________ What would be the design/timeline of such trial considering PG most likely will be FDA approved before trial start? — Too early to confirm at this point in time. Will it be a simple PK trial demonstrating that we can replenish the plasminogen level of a patient known to be deficient because of an acute episode or will we need to go for more specific endpoint? We will know after discussing with the regulatory authority but I’m not in position to provide info on this at the moment. ____________________________________________ With an 85% survival rate (should read: mortality rate:** see original corrected) and few months average survival time, we should be looking at a relatively short trial. What are your expectations on duration of trial? — I would indeed think that this would not require a long trial. It may even be as simple as by how much time are you cutting down hospitalization time during these acute episodes…again, we will know a lot more once we will have had the opportunity to sit down with the regulatory authority to discuss. Jim

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