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Re: DesktopDR post# 562

Wednesday, 11/14/2018 11:24:23 AM

Wednesday, November 14, 2018 11:24:23 AM

Post# of 5583
So let's start with a brief recap of the trial history and data as presented to investors on September 5th and as we presented to the FDA and the briefing package for our recent Type C meeting. The 249 patient Phase III NeoCart trial is the first randomized well-controlled clinical trial conducted in the United States that was developed with FDA input. We narrowly missed statistical significance versus microfracture with control arm in the evaluation and the primary endpoint. The company chose a much higher hurdle responder analysis as the primary endpoint in 2009 prior to the FDA's formal guidance in 2011, which covers products approved in 2016 as well as those under development today.

In the primary endpoint responder analysis in the modified Intent to Treat, or mITT population, 74% of NeoCart patients were responders at one year versus 62% of microfracture patients, missing statistical significance by just one or two microfracture responders. However, 62% of our NeoCart patients were statistically significant responders at six months versus 46% of microfracture patients. We also demonstrated statistical superiority in the dual threshold responder analysis on a variety of other covariate analyses such as in patients with BMI greater than 28 and then in lesions greater than 2.2 square centimeters, which we believe represent the broader patient populations treated by surgeons.

The underlying IKDC function and KOOS pain outcome data utilized conduct the responder analysis and other efficacy analyses were prospectively defined and collected and can be used to demonstrate efficacies in current FDA standards. On those FDA standards, NeoCart demonstrated both clinically meaningful improvements in pain and function from baseline versus microfracture and statistically significant improvements in both KOOS and IKDC endpoints as compared to baseline at one and two years.

These early and sustained improvements in pain and function results in meaningful clinical outcomes for patients. We also believe them to be compelling when compared to other products either in development or on the market. Based on the conduct of the NeoCart Phase III trial, the inclusion exclusion criteria and resulting patient demographics, our surgeons have remarked how meaningfully different than NeoCart results are when evaluating patients during follow-ups.

So why do we miss our endpoint? NeoCart performed well in the trial better than the statistical plan and better on virtually every endpoint analyzed. However, the microfracture control arms simply showed a treatment effect even greater than expected in the statistical plan. This is not a normal placebo effect whether it is well established that in the limited patient population with strict rehabilitation protocols, active controls or microfracture patients can do well for some period of time.

https://seekingalpha.com/article/4220807-histogenics-hsgx-ceo-adam-gridley-q3-2018-results-earnings-call-transcript?page=2
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