Biotech Values

[jq1234]

HPTX: The company did as well as it could after the fact, but it was a MAJOR due diligence failure.

Here is the published result from the study in question: http://care.diabetesjournals.org/content/37/5/1392.full.pdf

Total 457 patients randomized, only 349 patients included in primary efficacy analysis. How could patient disposition like below not raise alarming bell? Why wouldn't anyone ask for ITT result before finalizing the deal? Anyone with regulatory experience should know disposition/analysis like this can't be used for regulatory submission for diabetes indication.



Here is HPTX's PR announcing the deal:

In its first Phase 3 study, a randomized, double-blind, placebo-controlled, multinational trial, DiaPep277 demonstrated a significant reduction in beta cell loss as reflected by preservation of glucagon-stimulated C-peptide secretion relative to placebo. In addition, a significantly higher proportion of patients treated with DiaPep277 maintained target levels of glycated hemoglobin (HbA1c, a measure of metabolic control) and had a lower rate of hypoglycemic events versus placebo. Similar results in the ongoing confirmatory Phase 3 study could position DiaPep277 as the first disease-modifying therapy approved for Type 1 diabetes.

http://investors.hyperiontx.com/releasedetail.cfm?ReleaseID=842174