March 23, 2016 9:07am

 

Small and medium-sized enterprise (SME) status allows for fee reductions and waivers for some EMA regulatory filings.

 


 

 CYTX is preparing to engage with the EMA for discussions about program for impaired hand function from scleroderma

 

The Bottom Line: The primary aim of the SME initiative is to promote innovation and the development of new medicinal products by smaller companies. To achieve this, incentives are provided to help SMEs overcome the main financial and administrative hurdles associated with pre-marketing procedures, particularly scientific advice, marketing authorization application and inspection procedures.

Financial incentives for SME companies include a 90% fee reduction for scientific advice and quality inspections of facilities along with fee deferrals. SME companies are also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other financial incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process.

 

CYTX needs to re-structure their outstanding shares and float to truly capitalized on this positive news for any true appreciation.

 

CYTX had closed UP +$0.0114 to $0.186 with 1 M shares traded <3 month average =1.44 M shares>