Thanks Larry and Myra.

As it turns out, the PI was confusing a Phase II clinical trial with a Phase II SBIR.  So, it is a Phase I (for a Phase II).

Ours is a farraginous lexicon.

CH

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@lists.healthresearch.org] On Behalf Of Lawrence Koepfle
Sent: Tuesday, April 05, 2011 1:13 PM
To: xxxxxx@lists.healthresearch.org
Subject: Re: [RESADM-L] SBIR/STTR Q

Charlie,

The usual mantra about "discuss your particular situation with NIH program staff."
But you can take heart that you can do something, like a "fast-track" application.

From the FAQ's:

"What is a Fast-Track award?
Fast-Track incorporates a submission and review process in which both Phase I and Phase II grant applications are submitted and reviewed together as one application. Because both phases undergo review at the same time, the NIH Fast-Track mechanism can reduce or eliminate the funding gap between phases."

And

"Is it permissible to submit a budget that deviates from the time and dollars normally awarded to Phase I or Phase II?
Yes. Applications submitted in response to the SBIR and STTR parent funding opportunities may deviate from the budgetary and project duration guidelines ($100K for Phase I and $750K for Phase II) but must be well justified. Applicants are encouraged to discuss budgetary deviations with NIH Program Staff prior to submission of the application. Applications submitted in response to a specific targeted FOA must abide by the requirements in the FOA."

I would aggressively interpret these to mean that if you talk with the NIH staff, you can address your particular situation.    Worst case, your Phase 1 will be extremely brief.

Larry

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@lists.healthresearch.org] On Behalf Of Myra Keeble
Sent: Tuesday, April 05, 2011 12:36 PM
To: xxxxxx@lists.healthresearch.org
Subject: Re: [RESADM-L] SBIR/STTR Q

Nope, but you can do a Fast Track application that incorporates a mini-Phase I, using your initial work as preliminary research to help make the case for a shorter timeline. The Fast Track combines Phase I and Phase II into one application. It's risky because you can't break apart these two applications. It's reviewed as one application.

Myra Keeble, Grants Manager
Klein Buendel, Inc., 1667 Cole Blvd., Ste. 225, Golden, CO  80401 xxxxxx@kleinbuendel.com; www.kleinbuendel.com
(303) 565-4333 (Office); (303) 565-4320 Fax

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@lists.healthresearch.org] On Behalf Of Charles Hathaway
Sent: Tuesday, April 05, 2011 10:26 AM
To: xxxxxx@lists.healthresearch.org
Subject: [RESADM-L] SBIR/STTR Q

May one apply for a NIH Phase II SBIR/STTR without having received a Phase 1?

(Phase 1 work done w/o federal support).

Thanks

Charlie Hathaway

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