This is termed the “central dogma” of biology. We are developing “anti-gene” therapies. Anti-genes are similar, but distinct, from antisense oligonucleotides (ASOs). Stability of peptide nucleic acids in human serum and cellular extracts. doi: 10.1016/0006-2952(94)90171-6. Erratum in: Mol Ther Nucleic Acids. PMID: 26440599; PMCID: PMC4881755. There are currently no approved treatments available to slow the progression of HD. Any agency or judicial enforcement action could have a material adverse effect on us. & A sponsor may also voluntarily propose a REMS as part of the NDA submission. Once adopted, REMS are subject to periodic assessment and modification. & This summary does not address all of the risks that we face. Several of our employees work remotely. In particular, third-party payors may limit the covered indications. The negotiation process in some countries can exceed 12 months. Our financial statements have been prepared in accordance with U.S. GAAP. These formulations may be covered by intellectual property rights held by others. Such challenges may result in loss of exclusivity or freedom to operate. Moreover, the length of the extension could be less than we request. We and the individuals dispute these claims and intend to defend the matter vigorously. The defendants dispute the claims raised in the Wheby Action.
