Mast Therapeutics, Inc. (MSTX)

[BooDog]

In plain English Rhodey. Thank you. Nice momentum starting to pick at resistance as we get closer.

Patience.

Today's reply (yes on a Sunday) from Ioana regarding my query for updated timeline information.
Thanks for reaching out. It is difficult to estimate or offer timing around the “typical or average” QA/QC process for Phase 3 studies because it can vary significantly. The size of a study, the number and location of participating study sites, and the amount of data points collected are some of the many factors that affect this timing. EPIC in particular is unique because there have been so few placebo-controlled, Phase 3 studies in sickle cell crisis and EPIC is larger than any of the previous studies.
I would like to provide you with a brief overview so that you may understand the scope of the process, which is detailed and rigorous so that the data generated from the study can be considered high-quality, reliable and statistically sound.

As you know, all patients enrolled in EPIC must complete a 30-day safety follow-up visit per study protocol and, depending on the patient, there could be additional follow-up that extends beyond this 30-day period. The blinded data assembled from all of the study sites must undergo a rigorous QA/QC process, during which it remains blinded, and will be queried as necessary by data managers and blinded biostatisticians for consistency, appropriate coding and reconciliation at individual site levels, at country and regional levels and at an overall study level. Once the blinded data has undergone this extensive QA/QC process, the database lock for EPIC can be effected. At that point, each individual investigator at each clinical site must review and sign off on the data under their specific oversight. Following this, transfers of blinded data occur to test if all programing done by the statisticians performs as intended. Finally, study unblinding can be performed only by the external study biostatistician. After the statistician’s work is complete, Mast will be notified of the top-line outcome of the study from the biostatistician. And at that point, Mast will be able to report study results to our stockholders.

I would like to remind you that EPIC is the largest, placebo-controlled study in sickle cell disease ever conducted at more than 75 clinical sites around the world. We are eager to share the results of EPIC with our stockholders, but, in the meantime, we ask for your continued patience as we perform a robust QA/QC process to help ensure confidence in the results.

Best, as always,
Ioana