This is pretty important part of that shareholder letter;
Although there can be no assurance, we anticipate that following completion of the Phase 1 study in November 2014, Shire will review the safety of VP 20629 and its possible effect on plasma/urine biomarkers of oxidative stress and thereby decide whether to move to Phase 2. Indication of positive biomarker effects could result in a decision by Shire to seek Orphan Drug designation for VP 20629. We have no ability to control Shire's decision as to whether to seek such designation.
Now it could be that Shire is aware of results from first part of study, as there are 2 distinctive groups within the study design. So have they decided as per their own release to move this to phase 2 already, as pointed out by some on the board, this study was only going to be a phase 1, and suddenly it's shown by shire as phase 1/2 study.
Even in Intellects own releases they have described this as Phase 1 study.
