Tuesday, July 10, 2018 5:54:04 AM
From where I sit, high up in the bleachers....this is what shareholders have to look forward to in the coming weeks and months.
-A 7th DSMB report and/or SSRA
Its been over 4 months now since the DSMB has chimed in, 6 times they've recommended the trial continue on with no changes recommended and no concerns listed about either safety or efficacy. An SSRA would be even better.
-Successful completion of BETonMACE and top line results. If things go reasonably close to how they seem to be planned the 250 MAC events should happen sometime late in the year.
-NDA application
-NDA approval
Each step has risks of course....but if each step is successfully achieved I like the chances for a PPS in and around the $10 mark by the EOY.
$5 with good SSRA, or maybe $3 to $4 with a 7th + DSMB report.
$10 if they're able to meet the BETonMACE primary end point with positive top-line data.
Then would come an NDA filing and hopefully approval. And obviously there could be other announcements along the way like licensing deals, the start of trials for CKD and Fabry's, further analyst coverage or media exposure.
If you want to taste the fruit, you have to go out on a limb. But if you wait for the herd to move out on the limb....the branch tends to snap.
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