Clinical Trial Failure Risk: PDSB's drug candidates are in various stages of clinical trials, and there is a significant risk that these trials may not achieve their primary or secondary endpoints, fail to demonstrate safety or efficacy, or encounter unexpected adverse events, leading to termination of development.

Regulatory Approval Uncertainty: Even if clinical trials are successful, obtaining necessary regulatory approvals from agencies like the FDA or EMA is a complex and lengthy process with no guarantee that PDSB's drug candidates will receive marketing approval, which would prevent commercialization.

Funding and Capital Needs: Developing new drugs is extremely expensive, and PDSB will require substantial additional capital to fund ongoing clinical trials, research and development, and potential commercialization, with failure to raise sufficient capital potentially delaying or halting operations.