Pop Open A Window — Watch the FDA Transparency Webcast — LIVE, Right Here!

This all has become so easy — there was a time when it actually took some coding abilities and “skillz” to offer up live webstreams from remote sites. No longer.

So, thankfully — all you now need do is click this FDA link, after 7:30 am EDT, on Wednesday, June 24, 2009.

. . . .The FDA will hold a public meeting on Wed., June 24, 2009, from 8 a.m. to 5 p.m. to solicit input from interested persons on ways the agency can make useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format. The public meeting will be held in downtown Washington, DC at the National Transportation Safety Board (NTSB) Conference Center, 429 L’Enfant Plaza, SW. Those who cannot attend the meeting may view the proceedings via webcast. . . .

A G E N D A

8:00 am Welcome and Introductory Comments
Joshua Sharfstein, MD, Principal Deputy Commissioner
Afia Asamoah, JD, MPP, Special Assistant to Principal Deputy Commissioner

8:15 am Panel 1
Gregory Meyer, Compliance Media Inc.
Janet Trunzo, AdvaMed (Advanced Medical Technology Association)
David Lim, Independent Consultant

8:45 am Panel 2
Francesca T. Grifo, Ph.D., Union of Concerned Scientists
Jeffrey Francer, PhRMA
Kristi Zonno, MS, CGC, Genetic Alliance

9:15 am Panel 3
Steven Findlay, Consumers Union
Bray Patrick-Lake, Consumer
Allan Coukell, Pew Prescription Project

9:45 am Panel 4
Daniel Fabricant, Ph.D, Natural Products Association
Sarah Janssen, MD, Ph.D, Natural Resources Defense Council
Kathy Means, Produce Marketing Association

10:15 am Break

10:30 am Panel 5
Bob Kelser, IDSN, Inc.
Kathryn Foxhall, Freelance Reporter

11:00 am Panel 6
Shannon Benton, The Senior Citizens League
Peter Lurie, MD, MPH, Public Citizen
Diana Zuckerman, Ph.D., Nat’l Research Center for Women &
Families

11:30 am Panel 7
Mark B. Leahey, Medical Device Manufacturers Association
Nancy Beck, Ph.D., Physicians Committee for Responsible Medicine
Sin Hang Lee, MD, Milford Medical Laboratory

12:00 pm Lunch

1:15 pm Panel 8
Emily Claire Napalo, Breast Cancer Fund
William H. Maisel, MD, MPH, Medical Device Safety Institute
Andrew Emmettt, Biotechnology Industry Organization (BIO)

1:45 pm Panel 9
Sarah Klein, The Center for Science in the Public Interest
Kiyo Oden, The Tatia Oden French Memorial Foundation
Carolyn Brubaker, Microsoft

2:15 pm Break

2:30 pm Open Comment Session

5:00 pm Meeting Adjourns

Is This Where Some of CEO Fred Hassan’s “Golden ‘Chute” Will Be “Deployed”?

Fascinating — CEO Fred Hassan’s son (Daniel) runs a Massachusetts-based nascent web-media “clickable TV” company — I wonder whether Dad is the source of some (most?) of the initial $15 million equity financing (or the now-pending additional $4 million)? This item, per Mass HiTech, a few minutes ago:

. . . .According to [the son, Daniel] Hassan, business operations will be split between New York and Boston, with New York starting off as a smaller operation. “Right now we are just going to look at it as a sales office and outreach office,” Hassan said. Backchannelmedia employs 29 workers.

[Daniel] Hassan, who has been chairman of the board as well as co-CEO since 2007, became sole CEO as of June 15. Hassan is son of Fred Hassan, CEO and chairman of New Jersey-based drug giant Schering-Plough Corp. . . .

Of course, clickable, at right, is Dad’s ‘chute estimate-graphic. Schering-Plough CEO Fred Hassan negotiated a “special grandfathering” of stock options, and other forms of equity compensation, for himself, and himself alone, in the event of a Change of Control, back in 2003, when he signed on — here’s his full employment agreement (the grandfathering is in Section 3(j) — on page 4).

$4.25 Billion of Merck Debt Securities Priced, at NYSE Close, Last Night. . . .

The graphic at right depicts the proportions, by maturity schedule, of the various debt tranches — as ever, click it to enlarge. As the AP reported overnight, Merck did go ahead and price the unsecured debt offerings it opened yesterday:

. . . .The company is offering $1.25 billion of 1.875 percent notes due 2011, $1 billion of 4 percent notes due 2015, $1.25 billion of 5 percent notes due 2019, and $750,000 of 5.85 percent notes due 2039. . . .

The closing of the offering will terminate the commitments of lenders and the company’s related obligations pursuant to a $3 billion bridge loan. It also will reduce the commitments of lenders under the asset sale facility by about $375 million. . . .

This offering takes the bank syndicate “off the hook” for a large chunk of the merger financing. It effectively places, in the public’s hands, the risk of a non-completion of the deal. That is a wise move by the bankers. In aggregate, remember, these bankers will likely make about $100 million in fees for advising on this deal.

As of June 25, 2009, the bankers’ exposure here will be greatly diminished [full Pricing Term Sheet, as filed with the SEC, here], should the proposed reverse merger transaction not be completed. Afterall, the reason these interest rates are available to Sch-Merck — and attractive to the public bondholders buying in the offerings — is that everyone assumes the deal will close. Should that turn out not to be the case — it is unlikely that Merck would be able to effectively service the debt, and still maintain its presently-envisioned capital structure, intact. Net-net: A smart move on the part of the banks.

Finally, while the offerings have been rated Aa3/AA-, there had been some talk, yesterday (now silenced) that Merck’s near term credit rating/outlook would be “negative” — meaning that the rating agencies might be rethinking their ratings on Merck’s corporate debt, and thus could announce a change at any time. Just FYI, Mr. and Ms. Merck/Schering-Plough Bondholder.

No FDA Approval of OTC Version of Zegerid Until Year-End 2009. . . .

This is waifish, especially when compared to the pro-forma revenues of the to-be-combined companies, but worthy of note, nonetheless — as it may be the way things go, generally, at FDA for Schering-Plough, for the foreseeable future.

MarketWatch has the scoop, this morning:

. . . .The Food and Drug Administration said it would act in December 2009 on Schering-Plough HealthCare Products’ new-drug application to market an over-the-counter version of Zegerid, a treatment for heartburn. . . .

Indeed. The NDA was filed in March of 2008, so that’s at least a one-and-three-quarters years-long timeline. And that’s very-nearly a “slow roll“. . . .