Sorrento Therapeutics Inc (SRNE)

[dia76ca]

Note that the top 3 technologies are being advanced using 505(b)2...
"The 505(b)(2) is a New Drug Application (NDA) mechanism which allows an applicant to seek approval for a drug product based on full safety and efficacy documentation, some of which may be from literature or conducted by others and for which the applicant does not have the right of reference.

Created in 1984, it is a streamlined process and does not require the applicant to conduct all the required studies or obtain a right of reference.

A 505(b)(2) can been used to get approvals for changes such as New Delivery Mechanisms, New Dosage Forms, New Formulations and New Indications. It has the advantage over the traditional process by being able to rely on previously published material, and so can be quicker as well as being lower cost"