Examples of Lead Product Candidate in a sentence
The Lead Product Candidate of the Company and its Subsidiaries has been developed, tested, manufactured and stored, as applicable, in compliance in all material respects with applicable law including, where applicable, the FDA Act and applicable regulations issued by the FDA, including, as applicable, those requirements relating to the FDA’s, EMA’s and other Governmental Entities current good manufacturing practices and good laboratory practices, and good clinical practices.
Verification of an absence requires a written notice from parents or guardians to the homeroom teacher.
Neither the Company, nor any of its Subsidiaries nor any of their respective employees or agents, have made an untrue or fraudulent statement to the FDA or any other applicable Governmental Entity, or in any records and documentation prepared or maintained to comply with the applicable laws, with respect to the Lead Product Candidate of the Company, or failed to disclose a material fact required to be disclosed to the FDA or any other similar Governmental Entity.
And as the cliché goes, whenever the US sneezes, the world catches a cold.
KSI-301: Our Lead Product Candidate Our lead product candidate, KSI-301, is a novel, clinical stage anti-VEGF biological agent that combines inhibition of a known pathway with a potentially superior ocular durability profile compared to currently marketed drugs for wet AMD and DR.
To the Company’s Knowledge, the conduct of the Business of the Company and its Subsidiaries does not and would not, if the Lead Product Candidate were sold as of the date of this Agreement, infringe, violate or constitute a misappropriation of any Intellectual Property of any third party.
Following the Closing, the Buyer shall, and shall cause its Affiliates (including the Surviving Corporation) and the other members of the Buyer Rights Chain Group to, use Commercially Reasonable Efforts to achieve each of the Developmental Milestones with respect to the Lead Product Candidate and to commercialize the ENB-0040 Product for HPP in each country in which the ENB-0040 Product receivesRegulatory Approval for the treatment of HPP.
The Parties will determine which Party will have responsibility for (A) the processing of the Lead Product Candidate which incorporates Vectors and associated Payloads supplied by Bluebird for use in any Clinical Studies [***], and (B) the processing of any other Product Candidates which incorporates Vectors and associated Payloads supplied by Bluebird for any Clinical Studies of such other Product Candidates [***].
Our Lead Product Candidate Our lead product candidate, AB101, is human recombinant insulin that has been formulated with a polymer in biodegradable microspheres for use in patients with type 1 and type 2 diabetes who require basal insulin replacement therapy for the control of hyperglycemia.
For more information, please visit www.oncotelic.com.About Oncotelic’s Lead Product Candidate, OT-101OT-101, the lead immune-oncology drug candidate of Oncotelic, is a first-in-class RNA therapeutic targeting TGF beta that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings.