An Important Reminder: On What I Can -- And Can't -- Say Here, About The FDA Approval Horse Race: Nivolumab, And MK-3475

Just fielded a great anonymous comment/question a few minutes ago, so I'll lay it out in full -- as it will remind newer readers of our policies, and the applicable law in the area.

And this blog will always adhere to the letter of the law. Without exception. Top line: Come here for what would be an alternate universe Wall Street analyst's take on all things Merck. Don't come here expecting to traffic in -- or garner -- material inside information in the classical SEC sense. Not happening. Not about Merck. Not about BMS, or any other company mentioned here (see below).

Without additional delay -- here is the comment:

. . .Anonymous said... @ 9:15 AM

What concrete info do you have on Nivolumab? What timeframe should we see the approval in? There were rumours BMS was delaying [its] anti-pd1....

February 7, 2014 at 9:24 AM. . . .

And my answer(s):

. . . .Condor said...

Thanks for stopping in, Anon.! --

You clearly know your stuff. Let me pay you the compliment of answering in fairly sophisticated, shorthand prose. A lot of the answer turns on nuances of SEC rules and releases and cases -- which would take a chapter to lay out for a true neophyte. . . but that isn't you. So, here goes:

My most recent, on the record pieces -- with concrete nivolumab updates -- are [see the comments box, two posts below].

Through my own research, and scientific journal readings, attending scientific conferences (and buying the right people drinks!), chats with academic contacts, and other cocktail conversation -- at public company biotech/pharma functions. . .

I have pieced together much, much more. But I won't trade on it. Ever.

The trick -- and frankly SEC problem, here -- is that almost anything on nivolumab that isn't already known to be true and in the public domain (from BMS or a similarly credible source) -- may be material to the securities trading prices of Bristol Myers Squibb common stock.

And I'll never endanger any off-the-record conversant, nor ever encourage (nor knowingly allow anyone I talk with) to execute a securities trade, on anything I received from someone who owed anyone else a duty of confidentiality -- as to the information.

As to Merck, that's easy. I only report on -- and analyze, here -- what is already public. My own take on it is no different than any Wall Street analyst. It is just one guy's opinion. Perfectly lawful, and appropriate. [I could even trade on it, though I almost never will.]

As to BMS, I'll rarely ever really know whether what someone has shared with me is simple idle speculation, or based on hard inside information.

And as I say -- very much like a journalist in this respect -- my sources are forever sacrosanct.

So -- all I can tell you, here -- since I do not know you, and know you to be worthy of trust -- is the BMS is far more conservative than Whitehouse Station has been of late, in making predictions about not yet FDA approved biotech cancer candidates, nivolumab chief among them. [And even so, Merck is not officially guessing at an approval date for MK-3475.]

Whitehouse Station is likely a little more cavalier, here because almost no MK-3475 revenue is baked into today's NYSE price. And it is a smaller piece of Merck's pie than Nivolumab will be to BMS, each upon approval. So, no one can really complain if Merck finishes more than six months behind BMS -- if Merck is. . . wrong.

And the truth is, I still believe, based on all I know, that BMS will -- as to the largest/deepest markets, i.e., label indications, here -- beat Merck by six months or more, inside the US (get FDA approval first).

But I could be wrong. And of course, oncologists can always write off-label, if Merck gets a narrow label, at first.

Then the trick will be getting insurers, Medicare/Medicaid and the nascent ACA exchanges to fully reimburse the perhaps $120,000 per patient dosing price -- for either MK-3475, or nivolumab.

More on that, another day. . . .

Thank you so much for the questions!

Do stop back!

Namaste

February 7, 2014 at 9:55 AM. . . .

Keep calm and carry on [or "carry one," if you prefer].