Subject: RE: ldt - 60 day fda clock
From: "Neil Callahan" <[email-masked]>
To: "Eric Schwerin" <[email-masked]>
Cc: "John DeLoche" <[email-masked]>, "Hunter Biden" <[email-masked]>, "Rob Walker" <[email-masked]>, <[email-masked]>, "Devon Archer" <[email-masked]>, "William Lee" <[email-masked]>, "Neil Callahan" <[email-masked]>
Date: Thu, 31 Jul 2014 17:27:42 -0400

No rush, just having something on our letter head with our recommendation
and showing our thought process and where our value add ends and where
bringing on firms that can move forward would be great.  An example of
“giving them a path” as RHB describes.  Also shows an artifact/deliverable
of our value add that we can share  in our fundraising efforts!

Thanks Eric

Neil Callahan

Co-Founder & Managing Director

Rosemont Seneca Technology Patners

152 West 57th Street, 47th Floor

New York, New York 10019

917-945-9516

www.rstp.com

*From:* Eric Schwerin [mailto:[email-masked]]
*Sent:* Thursday, July 31, 2014 4:19 PM
*To:* Neil Callahan
*Cc:* John DeLoche; Hunter Biden; Rob Walker; [email-masked]; Devon Archer;
William Lee; Neil Callahan
*Subject:* Re: ldt - 60 day fda clock

I can draft something - may not be until Monday though.  I’ll circle back
with Hunter and Rob and see what firms we think make sense for this.

Eric D. Schwerin

Rosemont Seneca Partners, LLC

1010 Wisconsin Ave., NW

Suite 705

Washington, DC 20007

(202) 333-1880

[email-masked] <x-msg://59/[email-masked]>

*P* *Consider the environment before printing this email.*

On Jul 31, 2014, at 3:58 PM, Neil Callahan <[email-masked]>
wrote:

Agreed, they need to deploy capital to this part of their business as  a
defensive move to protect the franchise.

Can we come up with a list of firms we'd recommend and the names of the
principles we know?   John could serve this short list up to the company to
action.

Also, as part of our value add, could we write an Opinion Memo that lays
all this out with our recommendation?   I think this would show our work
and head off Counsyl from saying "I thought you guys would do this work for
us as part of your value add".

--------------------

Neil Callahan

Rosemont Seneca

917-945-9516

On Jul 31, 2014, at 3:49 PM, Eric Schwerin <[email-masked]>
wrote:

From my brief read on this the 60 day window is just FDA meeting is
requirement to notify Congress 60 days before publishing a request for
public comment in the Federal Register.

Before any agency makes a new regulation or rule change they must publish
it in the Federal Register and allow for a public comment period.  Very
standard procedure.  Many times they need to notify Congress before doing
so.

Once that request for public comment is published Counsyl can decide if it
wants to make a comment or not.  Ultimately, it sounds like FDA is thinking
of increasing regulations on LDT’s, which I am assuming is not ideal for
Counsyl.

I think this is a great data point to support our argument that Counsyl
hire a firm or team in DC to work on public affairs/government
relations/regulatory affairs and do so ASAP.  FDA regulations is a very
technical area and they need to find the right firm(s) to help them with
this and I don’t think should rely on an in house person.  Also, the
decision on whether to comment publicly is something Counsyl should weigh
as part of an overall public relations strategy as their comments will be
out there for all to see.   And if they feel there is a potential
regulation that will hamper their business they want to be up on the Hill
now telling the Counsyl story and asking members to support their case with
the FDA.

Hunter and Rob may have other thoughts.

Best,

Eric

Eric D. Schwerin

Rosemont Seneca Partners, LLC

1010 Wisconsin Ave., NW

Suite 705

Washington, DC 20007

(202) 333-1880

[email-masked] <x-msg://59/[email-masked]>

*P* *Consider the environment before printing this email.*

On Jul 31, 2014, at 2:27 PM, John DeLoche <[email-masked]>
wrote:

FYI. Let's discuss and form a plan on this.

Sent from my iPhone

Begin forwarded message:

*From:* Ramji Srinivasan <[email-masked]>
*Date:* July 31, 2014 at 1:43:12 PM EDT
*To:* John DeLoche <[email-masked]>
*Subject:* *ldt - 60 day fda clock*

John - see attached, let's plan to discuss as soon as possible.

The 60 day clock for notification to congress just started today.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm407321.htm

http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/UCM407409.pdf

http://blogs.fda.gov/fdavoice/index.php/2014/07/curbing-risk-not-medical-innovation-in-personalized-medicine/

-Ramj