COMMITMENTS AND CONTINGENCIES |
9 Months Ended | |
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Sep. 30, 2018 | ||
| Commitments and Contingencies Disclosure [Abstract] | ||
| Commitments and Contingencies Disclosure [Text Block] |
8. COMMITMENTS AND CONTINGENCIES Leases - On June 4, 2018, the Company entered into an Agreement of Lease. The Company will lease 3,983 square feet commencing on the date on which the tenant improvements being conducted have been substantially completed and for a term of 64 months from the commencement date. The Company also has an option to extend the term of the lease for one additional 60-month period. The landlord has agreed to provide the Company a contribution of up to $179,235 to the total cost of the tenant improvements. The anticipated completion date is expected during fourth quarter 2018 upon the Company taking possession and control of the physical use of the space.
Under the terms of the lease, the Company must pay 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 will also be required to pay its proportionate share of certain operating expenses and real estate taxes applicable to the leased premises. The Company has agreed to extend its lease payments for its Madison, Wisconsin facility from September 14, 2018 to January 14, 2019. This additional time is needed for the Company to remove certain alterations, additions, and improvements required upon termination of the lease. Since this facility is no longer used by the Company, as of September 30, 2018 the company has recorded a liability of approximately $267,000 needed to meet its remaining obligations under the lease. Supply of CLR 131 - On August 7, 2018, the Company was informed by Centre for Probe Development and Commercialization (“CPDC”), the Company’s sole supplier of CLR 131, that CPDC is subject to an Import Alert 66-40 (the “Import Alert”) by the United States Food and Drug Administration (“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 the Company until the Import Alert is lifted or alternative agreements are reached with the FDA. On September 24, 2018 the Company announced that the FDA had initiated direct talks with the Company concerning a possible exemption for CLR 131 from the Import Alert.
On November 8, 2018, the FDA notified the Company that it has completed its initial review concerning a possible exemption for CLR 131 from the Import Alert placed on CPDC. The FDA authorized CPDC to send shipments to the investigator sites participating in the Company’s ongoing hematology focused clinical trials, including our Phase 2 clinical study for relapsed or refractory multiple myeloma and a range of other B-cell malignancies, and its Phase 1 clinical study for relapsed or refractory multiple myeloma. As a result, the Company plans to resume patient enrollment in those clinical studies.
The Company awaits authorization from the FDA for any future shipments in connection with its Phase 1 study of pediatric patients with neuroblastoma, sarcomas, lymphomas (including Hodgkin’s lymphoma) and malignant brain tumors. As a result of the supply disruption, the Company is experiencing delays in patient enrollment for this clinical trial. At this time, the Company is not able to assess the extent of the delays or what impact the supply disruption will have on the Company, but the inability of CPDC to supply CLR 131 for this trial on a prolonged basis would result in further delayed patient enrollment. The Company intends to continue to work with CPDC and the FDA to resolve this issue as soon as practical.
Legal - 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.
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