Marker Therapeutics Inc (MRKR)

[hanscott]

Hi Flyingj. Below is the paragraph I think you are referring to and also a link to the FDA site detailing the process for approval for Vaccine/Biologics License Applicaion (BLA). I think the 10Q is sort of generically saying that the data from that particular Phase II would be part of an application at some point in the future, and not saying that they are necessarily currently preparing an application for the license. The FDA site makes it clear a Phase III is part of the process.

As for a time frame for approval, the estimated time for completion of this Phase II is December 2021 according to the clinical trial data at the link at the bottom. So even if they start an overlapping Phase III it is likely to be at least 4-5 years before they submit a BLA.

"

On June 21, 2016, we announced the initiation of a randomized four-arm Phase II trial of TNBC that is sponsored and conducted by the Company (FRV-002), enrolling women with stage I-III disease who have completed initial surgery and chemo/radiation therapy. This open-label, 80-patient clinical trial is designed to evaluate dosing regimens, pre-treatment, efficacy, and immune responses. The study is evaluating two doses of TPIV200 (a high dose and a low dose), each of which will be tested both with and without immune priming with cyclophosphamide prior to vaccination. Key data from the trial is expected to be included in a future Biologics License Application submission to the FDA for marketing clearance. We completed enrollment in late 2017 and are now treating and following the patients. An independent Data Safety Monitoring Board (DSMB) reviews the safety in this ongoing Phase II study; no safety issues have been identified to date. Details regarding this trial can be found at www.clinicaltrials.gov under the identifier number NCT02593227." Paragraph 2, p. 16

http://app.quotemedia.com/data/downloadFiling?webmasterId=102648&ref=12546966&type=HTML&symbol=MRKR&companyName=Marker+Therapeutics+Inc.&formType=10-Q&formDescription=Quarterly+report+with+a+continuing+view+of+a+company%27s+financial+position&dateFiled=2018-11-13#a_008



Vaccine Product Approval Process

https://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicslicenseapplicationsblaprocess/ucm133096.htm

TNBC clincial trial:
https://clinicaltrials.gov/ct2/show/NCT02593227?term=NCT02593227&rank=1

Study Type : Interventional (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination With Folate Receptor Alpha Peptides With GM-CSF in Patients With Triple Negative Breast Cancer Defined as Primary Tumor That is Her2-neu and Low (< 10%) ER/PR Nuclear Staining
Actual Study Start Date : April 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021