Indication intelligence, analysis and sector perception

Biostage (BSTG) Files for FDA Orphan Drug Designation

June 29, 2016 8:59am

BSTG has submitted an application with the U.S. FDA for its Cellspan Esophageal Implants.

The Orphan Drug Act of 1983 provides a range of incentives to encourage research and development investment in treatments for rare medical conditions. These incentives include seven-year market exclusivity commencing on product approval; tax credits; assistance in regulatory proceedings – fast-track registrations; and full exemption from the FDA's drug registration fees.

The Bottom Line: This submission is the first step in an effort to secure orphan status for the Cellspan esophageal implant, which BSTG “believes” has the potential to be a valuable option in the treatment of esophageal cancer.

A “check” the box endeavor … after yesterday's "spurt" of $0.10 and today's "endevour", will the day traders "skim" the upside?

BSTG closed at $1.13 with a pre-open indication of +$0.07 or +6.19%

To receive orphan drug designation, a company must demonstrate that the condition addressed by the drug or biologic affects less than 200,000 persons in the U.S. The company must also provide the FDA with sufficient information to establish a medically plausible basis for expecting the product will be an effective treatment.

35 companies, 1 interpreter!

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