Friday, February 7, 2014

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!


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

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


Anonymous said...

Sincere Mr. Namaste,

I want to thank you for you answer to my questions. I do apologize for not being more clear in my first questions.
I have never had, don't have and never will have any interest in money or stocks. (And therefor don't know anything about regulations for what i also apologize). The only thing I do have is a 28 year old sister with Stage4 melanoma. And with us THOUSANDS are waiting this approval for their loved ones. I understand the policies and maybe needing more trails, that's one thing. But why announce it as it is the holy grail and then delaying it without new trails and without compassionate use? To maximize profits from Yervoy? To stimulate stocks and buyers? It's the only conclusion i can make. So while BMS' CEO may be nipping their cocktails in Dubai, we can only hope my sister will be around long enough to see her 3year old grow up. (She now is doing excellent on a Merck combo by the way. Thank you Merck!) So I want to apologize barching in what appears to be businessblog with my emotions and story. With all my heart I hope BMS will surprise us all with an application or approval even maybe so thousands of people can have hope again. I wish you all the best with this blog and the future. I hope to return very soon to read spectacular news!

Condor said...

Let me just say Anon., that I will keep your sister in my morning meditation...

I trust that she will come to peace -- with whatever the future path through the Universe holds for her -- you are a good brother, and that improves her path appreciably...

I am sorry if I sounded officious -- my apologies.

It sure seems she'd qualify to be enrolled in either the Merck or BMS anti-PD1 clinical trials. But if what she is taking is helping -- I'd ride that pony!

Do stop back and let us all know how she fares. This is a business blog, but we are all humans here too. We have sisters we love, too.

Namaste, man!