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Replies to post #250994 on NorthWest Biotherapeutics Inc (NWBO)
11/11/19 2:27 PM
Not suggesting there are any obvious parallels here, but the whole
FDA hold procedure is often far from transparent.
This one sounds like a CMC issue.
11/11/19 2:40 PM
1.REGENXBIO challenges the Food and Drug Administration’s (“FDA”) clinical hold order on its potentially life-changing treatment for retinal diseases that lead to blindness. FDA’s final agency action is contrary to law and arbitrary and capricious because it did not follow the statute or its own regulations, nor did FDA offer a reasoned explanation for issuing a clinical hold without advance warning. The clinical hold also violates the Fifth Amendment’s Due Process Clause by depriving REGENXBIO of a protected interest without even the most basic procedural protections. In addition, Section 505(i)(3)(B)(ii) of the of the Federal Food, Drug, and Cosmetic Act (“FDCA”)—which authorizes FDA to issue clinical hold orders—is unconstitutional because it delegates unfettered discretion to FDA to issue a clinical hold order for “such other” extra-statutory “reasons as [FDA] may by regulation establish.” 21 U.S.C. § 355(i)(3)(B)(ii).
2.REGENXBIO was founded with the goal of improving lives through the curative potential of gene therapy. To that end, REGENXBIO has invested tens of millions of dollars in developing gene therapy for the treatment of retinal and other diseases. Most recently, REGENXBIO developed RGX-314 to treat the leading cause of blindness in the United States, wet age-related macular degeneration. The results of an interim clinical trial for RGX-314 were promising: RGX-314 was well tolerated by all forty-two patients, with patients at the higher doses tested experiencing stable to improved vision on average and an overall reduction in the need for alternative treatments to halt the course of the disease. Based on these results and discussions with FDA, REGENXBIO was on track to begin the next phase of clinical trials for RGX-314 before the end of 2019.
3.But on October 18, 2019, without notice or explanation, FDA placed RGX-314 on a clinical hold, effectively halting REGENXBIO’s development of this potentially life-altering treatment for retinal diseases that are leading causes of adult blindness. Since issuing the clinical Case 1:19-cv-03373 Document 1 Filed 11/07/19 Page 2 of 13
2hold order, FDA has rebuffed REGENXBIO’s repeated attempts to obtain an explanation of the basis for the clinical hold.
4.By failing to provide advance notice of, or any reasoned basis for, the clinical hold, FDA violated the FDCA and its own regulations. FDA’s clinical hold on RGX-314 is therefore contrary to law and arbitrary and capricious under the Administrative Procedure Act (“APA”).
5.FDA’s clinical hold also violates the Fifth Amendment’s Due Process Clause because it deprives REGENXBIO of a protected interest without notice or an opportunity to be heard.
6. In addition, Section 505(i)(3)(B)(ii) of the FDCA—pursuant to which FDA issued the clinical hold in this case—is an unconstitutional delegation of legislative authority from Congress to the Executive. The statute gives the Secretary of Health and Human Services unfettered discretion to promulgate regulations governing when a drug may be placed on clinical hold, but it fails to provide any intelligible principle to guide the Secretary’s discretion. The Court should declare this provision of the FDCA unconstitutional and enjoin its enforcement. JURISDICTION AND VENUE
7. This Court has jurisdiction over this case pursuant to 28 U.S.C. § 1331 because the claims arise under the APA and the United States Constitution. See 5 U.S.C. § 701.
8. The Court has authority to grant declaratory relief and to vacate and set aside the clinical hold pursuant to the Declaratory Judgment Act, the APA, and the Court’s inherent equitable powers. See 28 U.S.C. § 2201; 5 U.S.C. §§ 702, 706.
9. Venue is proper in this district pursuant to 28 U.S.C. § 1391(e)(1)(A).
10. FDA’s clinical hold order is final agency action because it is the consummation of the agency’s decisionmaking process with regard to RGX-314, and it affects REGENXBIO’s right to continue clinical trials of RGX-314. See 21 C.F.R. § 312.42.
11. REGENXBIO has standing because it is suffering reputational, economic, and competitive injury caused by FDA’s clinical hold order, and those injuries are redressable by a court order setting aside the clinical hold. Case 1:19-cv-03373 Document 1 Filed 11/07/19 Page 3 of 13
11/15/19 6:14 AM
The FDA told the biotech it won’t give a green light to this test “until it submits to the FDA additional data points on transport stability of EB-101 to clinical sites.”
In a statement, the New York- and Cleveland-based company said it had been “working closely” with the U.S. regulator “to address and narrow open Chemical, Manufacturing and Controls (CMC) items and has been working to resolve this one item identified in the FDA clinical hold letter.”
