Near-term activities that underlie our business strategy include the following:
• Complete the EPIC study and seek regulatory approval of MST-188 in sickle cell disease . Enrolling subjects in our pivotal phase 3 study of
MST-188 in vaso-occlusive crisis of sickle cell disease is one of our top priorities. Although predicting the rate of enrollment for EPIC is subject to
a number of significant assumptions and the actual rate may differ materially, we expect to complete enrollment by the end of 2015. If study
results are positive, we plan to submit a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, based in large part
on the data from this study. MST-188 has fast track designation with the FDA for the treatment of vaso-occlusive crisis of sickle cell disease.
• Advance clinical development of MST-188 for use in combination with thrombolytics in complications of arterial disease . Thrombolytic
agents, such as tissue plasminogen activator, or t-PA, are used to break up or dissolve blood clots, which are often the cause of acute
complications, such as acute limb ischemia, stroke and heart attack. Data from experimental models and clinical studies demonstrate the potential
for MST-188 to improve outcomes in patients experiencing complications resulting from atherosclerotic and thromboembolic processes. We believe
that, based on the similar pathophysiology of atherosclerotic arterial disease (plaque-obstructed arteries reducing the flow of blood to tissue), an
agent that is effective in one form of occlusive arterial disease, such as acute limb ischemia, or ALI, also may be effective in its other
manifestations, such as thrombotic stroke. In March 2014, we initiated a phase 2, clinical proof-of-concept study in ALI that, if positive, not only
would progress development of MST-188 in ALI, but also could generate interest in developing MST-188 in stroke. We anticipate that enrollment
in the phase 2 study will take approximately 18 months.
Quickstoltz, I agree with you. As soon as there is any kind of positive news for this stock it will go up to about $1.40. You may look at it from a fundamental perspective, but for me it's all technical. I have a feeling it will happen very quickly too... within a few days after that triggering news.
Good luck to all!
Sentiment: Strong Buy
You truly are a shameless pumper, Quick.
Anyone with an ounce of pride who has called EVERYTHING wrong like yourself would have slipped away quietly by now, but you are still here embarrassing yourself day after day.
It's actually quite sad to see.
MST-188 has orphan drug designation for treatment of ALI in the U.S. and we plan to
submit an application for orphan designation in the European Union during the second quarter of 2014.
• Initiate clinical development of MST-188 in heart failure. We believe MST-188 may offer a new therapeutic approach for patients with heart
failure. In contrast to current treatments, such as vasodilators and beta blockers, which can indirectly improve heart function, MST-188’s
membrane sealant and hemorheologic activity may directly improve heart contractility and function. We previously announced that, in a
randomized, placebo-controlled, nonclinical study in a model of chronic heart failure, a single, two-hour infusion of MST-188 demonstrated
improved left ventricular systolic function that was significant immediately (at the end of MST-188 administration) and remained significant at
one week, and, in some cases, at two weeks, after MST-188 administration. In addition, MST-188 resulted in statistically significant and
progressive reductions in troponin-I and plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), at both one week and two weeks after
MST-188 administration. We are evaluating options for development of MST-188 in heart failure and plan to announce our clinical development
strategy later this year.
Evaluate the potential of MST-188 in resuscitation following major trauma . The potential clinical benefits of MST-188 in resuscitation
following major trauma (i.e., restoration of circulating blood volume and pressure) are suggested by the results of a variety of experimental models,
including statistically significant improvements in survival. If the survival advantage observed in experimental models can be demonstrated in
clinical studies, it would represent a multi-billion dollar opportunity and a significant benefit to both civilian and military populations. During
2013, we met with U.S. Department of Defense personnel to discuss potential collaborations in this area and, based on their feedback, in 2014,
we plan to conduct a nonclinical study of MST-188 in an experimental model of trauma. The results of this study, if positive, may generate
further interest in studying MST-188 as a resuscitation fluid following major trauma.
Oh well I tried and tried to post the rest of the Near Term business strategy as listed in the last 10K dated March 26th. Go and look at it all for yourself. Item 1: Business Scroll down just a little and look at the business strategy if you like. For what ever reasons something shut me down from copy paste.
The question has been asked what are we waiting for next? Well go read it. I did the best I could.
Testing on two three. L.O.L. Posts won't go through?
I suggest once again going and looking at the business strategy in the last 10K. Because more is to happen this year that what I managed to copy paste.