Found this. I guess it would help if you are dealing with...

Found this.
I guess it would help if you are dealing with existing chemo drugs.
So SPL were talking to the FDA in late February cleaning up the Jackie war and putting it to bed.
Late August would be 6 months.

SPL has always said they would license after Ph2 but maybe they’re not going do that without first getting Accelerated Approval that would make it much more valuable. Maybe that’s already under way.

The FDA’s Accelerated Approval Program is designed to expedite the approval of drugs that treat serious conditions and fill an unmet medical need. Here’s a brief overview of the process: 1 Surrogate Endpoint: The drug must show effectiveness based on a surrogate endpoint, which is a marker thought to predict clinical benefit (e.g., a lab measurement or radiographic image) but is not itself a direct measure of clinical benefit1 (https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program)2 (https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review). 2 Conditional Approval: If the surrogate endpoint data is promising, the FDA can grant accelerated approval, allowing the drug to be marketed while further studies are conducted1 (https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program). 3 Confirmatory Trials: The drug company must conduct post-approval studies to confirm the anticipated clinical benefit. These trials are crucial to verify that the drug indeed provides the expected clinical outcomes1 (https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program)3 (https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp). 4 Review and Potential Withdrawal: If the confirmatory trials show that the drug provides the expected clinical benefit, the FDA grants traditional approval. If the trials do not confirm the benefit, the FDA has regulatory procedures to potentially remove the drug from the market1 (https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program)3 (https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp).This pathway helps bring potentially life-saving treatments to patients more quickly while ensuring that the benefits are verified through rigorous testing.Is there a specific drug or condition you’re interested in regarding this process?