NIHEY2015002_Q A_as_of_20150514.pdf

Questions and Answers for NIHEY2015002 as of May 14, 2015

1. How will the test material be received?

Answer: We will arrange either live or cryopreserved material that may need to be cultured in their laboratory for a few days.

2. Will it be necessary to culture the cells in-house?

Answer: Yes, there may be a need to perform simple cell culture in house.

3. Will we need to seed the cells on the scaffold?

Answer: If you have the capability to do so, we will send our people to train your staff.

4. Will there be a scaffold without cells provided for controls?

Answer: Yes.

5. Is there any stability information on the cells used for injection? How are cells to be stored?

Answer: Cryopreserved. Thawed cells are stable during transplantation.

6. Can you please provide a description of the implantation procedure?

Answer: It’s a subretinal transplant or injection.

7. Are there specific markers of interest for IHC staining? If so, are reagents available?

Answer: RPE-specific and human specific.

8. Should development of the qPCR method be included in proposal? Are primers available? Or will samples be shipped to the sponsor?

Answer: Development of qPCR should be done during the the pivotal study. Yes, primers are available.

9. Is there an expected format for the Technical Proposal and Business Proposal? If so, please provide a summary document outlining requirements.

Answer: No. However, it is incumbent upon the offeror to carefully read the RFP and, in its proposal, address elements in the Statement of Work and the Technical Evaluation Criteria, both documents of which were posted as part of the RFP.

10. Would it be possible to extend the due date?

Answer: The due date for proposals was moved to June 10, 2015.

11. In order to further clarify (NIH’s answer to Question 1 of “Questions and Answers for NIHEY2015002 as of May 12, 2015) when you say approximately 200-250 animals for both combined, is that per dose group, or the total of all dose groups?

Answer: 200-250 is the total number of live animals we need for analysis. This does not include any mishaps that happen during procedures.

12. The presolicitation notice indicated that a cost reimbursement contract would be issued but the RFP indicates fixed price. Would the NEI still consider cost reimbursement in lieu of fixed price?

Answer: The RFP requests fixed price proposals. Any proposal other that what is requested shall be considered nonresponsive. The offeror may submit a second, mutually exclusive proposal using cost reimbursement methodology should it feel compelled to do so.