Lisata Therapeutics Inc (LSTA)

[F1ash]

Near the end of the video he says something that to my mind is what is currently influencing the share price. Paraphrasing: "We should be going to market in late 2017/early 2018." Traders hate to wait 2 weeks for results much less 2 years. I wonder if the surrogate end points could speed the drug to market.

"Primary Outcome Measures:

Overall survival [ Time Frame: 52 months ] [ Designated as safety issue: No ]
The time frames are estimated time in months (rounded up to the nearest month) from the start of study. The time estimates for the analyses are based on enrolling approximately 250 patients over a 34.8 months period and having a follow up of approximately 17 months after the last patient is enrolled."

https://clinicaltrials.gov/ct2/show/NCT01875653?term=caladrius&rank=1

"Accelerated approval: While the previous designations are aimed at making the FDA’s review of a new drug faster, the accelerated approval mechanism actually changes the basis on which a new drug can be approved.
A company whose drug is designated a breakthrough therapy gets advice and meetings from the FDA early in the drug development process, involvement of senior FDA staff members and other experts, and the ability to submit parts of the new drug application as they become finalized.

In general, approval of a company’s application to market a new drug requires studies that show an effect on an endpoint that clearly reflects clinical benefit, such as an improvement in function or survival.

Endpoints, also called outcome measures, are the measurements taken during a clinical trial. For example, if the goal of the treatment is weight loss, then change in weight would be a good endpoint for the trial. If the goal of the treatment is migraine headache prevention, a good endpoint would be the number of headaches in a given time period.

The accelerated approval mechanism, added to FDA regulations in 1992 for treatments for serious or life-threatening illnesses, allows regulators to use what is called a surrogate endpoint rather than a true endpoint as a measure of a drug’s effect in a trial. These substitute endpoints are particularly useful in conditions where a true endpoint, such as survival time or avoidance of disability, would require exceptionally long or exceptionally large clinical trials.


The FDA defines a surrogate endpoint as an outcome measure that is either known to predict a clinical benefit or is “reasonably likely to predict clinical benefit” but does not itself reflect a direct clinical benefit.

A mainstream example of a surrogate endpoint is blood cholesterol level, which is associated with clinical benefit but does not directly show clinical benefit in some cardiovascular conditions. Other surrogates include shrinkage of a tumor, which is reasonably likely to predict clinical benefit in some cancers but does not necessarily do so; and shortterm reduction of viral levels, which is reasonably likely to predict clinical benefit in HIV/AIDS but is not a clear indicator of long-term benefit."

http://quest.mda.org/article/not-too-slow-not-too-fast