Item 1. Legal Proceedings
Item 1. Legal Proceedings
From time to time, we are subject to claims in legal proceedings arising in the normal course of business. To our knowledge, during the six months ended June 30, 2024, there were no, and as of the date of this Quarterly Report, there are no, threatened or pending legal actions that could reasonably be expected to have a material adverse effect on our business, financial condition, results of operations or cash flows.
Item 1A. Ris k Factors
You should carefully consider the risk factors described in our 2023 Annual Report under the caption “Item 1A. Risk Factors.” The risks described in our 2023 Annual Report are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.
We have been selected for participation in the START Pilot Program, however this may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that we will receive marketing approval.
In May 2024, we announced that the FDA’s CDER had selected nomlabofusp as one of a few programs for participation in the START Pilot Program. The objective of the START Pilot Program is to accelerate the development of drugs for rare diseases that lead to significant disability or death by facilitating frequent advice and regular communication with the FDA staff to expedite the review process for biologics and drugs. As a pilot program, this expanded communication process will test if reducing wait times associated with the formal FDA meeting process accelerates the pace of development for products intended to address unmet medical needs. Because the START Pilot Program is newly launched by the FDA, its potential advantages are uncertain. While we anticipate that participation in this START Pilot Program may assist us in completing our BLA submission and approval timelines, there can be no assurance that the START Pilot Program will accelerate our development timelines or likelihood of approval for nomlabofusp. In addition, the FDA could withdraw our selection for participation in the START Pilot Program at any time.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
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