NIHEY2015002_Q A_as_of_20150512.pdf
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- Attached to
- NEI Toxicity Studies to Support an IND Filing for Conducting Phase I Study of iPSC-Derived RPE on Scaffold
- Solicitation number
- HHS-NIH-OD-PS-15-001
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Other files
| File | Type | Posted |
|---|---|---|
| NIHEY2015002_Q A_as_of_20150514.pdf | ||
| NIHEY2015002_Toxicity_RFP_Pkg.pdf | ||
| PS_Toxicity_SOW_20150222.pdf |
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Questions and Answers for NIHEY2015002 as of May 12, 2015
1. For studies 2a and 2b, how many animals per group will be required?
Answer: Approximately 200-250 for both combined
2. For studies 2a and 2b, will there be multiple groups receiving the RPE sheets?
Answer: We may do two groups with two doses of RPE sheet and one empty scaffold group only (approximately 100-150 animals)
3. Will the FDA require IHC in tissues other than eyes to determine cell migration?
Answer: FDA does require IHC in non-ocular tissue for a selected subset of animals.
They also require that tissues are appropriately preserved in case they want to see more data.
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