Quarterly report pursuant to Section 13 or 15(d)


3 Months Ended
Mar. 31, 2019
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies Disclosure [Text Block]
Real Property Leases
Florham Park, New Jersey
On June 4, 2018, the Company entered in an Agreement of Lease for 3,893 square feet for its new corporate headquarters in Florham Park, New Jersey. The lease commencement date was October 2018 and terminates
in February
The Company has an option to extend the term of the lease for one additional 60-month period.
Under the terms of the lease, the Company paid a security deposit of $75,000 and the aggregate rent due over the term of the lease is approximately $828,000, which will be reduced to approximately $783,000 after certain rent abatements. The Company is required to pay its proportionate share of certain operating expenses and real estate taxes applicable to the leased premises. After certain rent abatements the rent is approximately $12,500 per month for the first year and then escalates thereafter by 2% per year for the duration of the term.
Madison, Wisconsin
This space was vacated in 2018 as a result of our decision to outsource our manufacturing. The company additionally extended the lease on a month by month basis through February 6, 2019 to accommodate certain alterations required under the lease agreement. As of March 31, 2019, the Company has fulfilled the remaining obligations under the lease, which facilitated the release of the Certificate of Deposit of $55,000 required under the Company’s lease agreement for the facility.
The Company presently rents office space in Madison consists of approximately 300 square feet and is rented for approximately $3,300 per month under an agreement that expires on August 31, 2019.
The Company is involved in legal matters and disputes in the ordinary course of business. We do not anticipate that the outcome of such matters and disputes will materially affect the Company’s financial statements.
Supply of CLR 131
On March 19, 2019, the Company announced that the U. S. Food and Drug Administration (“FDA”) had granted an exemption to the Import Alert 66-40 (“Import Alert”) placed on Centre for Probe Development and Commercialization (“CPDC”) for the use of CLR 131 in connection with the Company’s pediatric Investigational New Drug Application (“IND”). As previously announced on November 12, 2018, the FDA had granted an exemption to the CPDC Import Alert for our hematology IND. This exemption allows the Company to enroll patients in all of its ongoing and planned clinical trials. CLR 131 is no longer subject to the CPDC’s Import Alert for any of the Company’s existing INDs.
On August 7, 2018, the Company was informed by CPDC, our sole supplier of CLR 131, that CPDC was subject to the Import Alert by the FDA. While the basis for the Import Alert was not related to CLR 131, or CPDC’s production facility associated with CLR 131, CPDC informed the Company on August 8, 2018 that CPDC would not be able to supply CLR 131 to it until the Import Alert is lifted or alternative agreements are reached with the FDA.