...and with '113, we won't be blindsided by the FDA's labeling rules.

I've already mentally committed to calling in myself to ask about broad population AEs in the pivotal '113 trial if it isn't something that they offer or analysts ask about.

If the '113 registration trial is designed like Pona's, I think it would be enormously helpful this time around for HB to offer the total universe of (S)AEs and then break out a subset that clinicians view as drug-related in the results presentations.

Whether we get that kind of transparency, we'll have to see.

Also, it might be useful to revisit what they said about all those adverse events that the FDA required on the label:

It kind of makes you wonder just how many CML patients there are out there who are not being treated either directly by one of these 16 doctors or whose oncologist isn't in contact with one of them.

I mean, honestly -- whose left?

If this is the roster of folks who think Iclusig's label is better described as 'over-inclusive' than 'disturbing,' I wonder what the rest of the oncology community thinks?

According to BLK's Nov. 13 13F, they seemed to hold about 335,000 in four funds.

These might be included in Jan's figure....

From the 11-13-2012 13F:

Included funds:
2 028-04293 BlackRock Financial Management, Inc.
3 028-14241 BlackRock Investment Management (Taiwan) Limited
4 028-13496 BlackRock Investment Management (Australia) Limited
5 028-12197 BlackRock (Channel Islands) Limited
6 028-12607 BlackRock Asset Management Australia Limited
7 028-06608 BlackRock Asset Management Canada Limited
8 028-13740 BlackRock (Isle of Man) Limited
9 028-13738 BlackRock Fund Managers (Isle of Man) Limited
10 028-14949 BlackRock Investments Canada, Inc.
13 028-15053 BlackRock (Singapore) Limited

Ariad line items:
ARIAD PHARMACEUTICALS INC 2 250650
ARIAD PHARMACEUTICALS INC 4 36100
ARIAD PHARMACEUTICALS INC 6 1079
ARIAD PHARMACEUTICALS INC 7 47288

Indeed -- thanks for posting! +1

(EDIT: I had intended to reply to lax's post -- this makes little sense as a reply to my own....)

Well, now we know where the prescription data comes from.

IMO, it's also pretty funny to say "can't give specific numbers" (again!) but then say the Rx figure is "exactly the same" as a data point that might be floating around out there (for those more industrious than I).

I suppose the other take away is that the Yahoo board isn't pure meta-schlock and name calling.

This is an interesting interview with Mauro about Pona -- not too much new, but some interesting color on the inside-baseball-type stuff:

“Borne Out of Necessity and Data”: Conquering Mutations in Leukemia

I found this a bit surprising:

Kind of makes you wonder what the numbers looked like in all those partnership deals that HB turned his nose up at.

Ariad was broadcasting pretty widely that it was all hot to trot to partner Pona and '113 for a fair period of time -- it strains credulity to imagine that they didn't ever get a serious offer.

Or maybe they were all gun-shy after seeing Merck get sold a pig in a poke....

Well, I suppose that conclusion is possible if one thinks that '133 has a 45% chance of approval in either ALK+ or EGFR+ NSCLC.

If you think that chance is greater....

Good -- I wasn't a fan of the delay, but was hoping that they'd use it to report full Feb. Iclusig prescription data.

I know.

The stat was so specific and prompt, it sounded like it came from a SAC-type "consultant lunch" with an ARIA employee or a hacker who had access to everyone's medical record everywhere.

But before we go down the tin-foil-hat rabbit hole, none of that type of info ever makes it into a sell-side analyst report -- even one you pay for.

I wonder whether they've been sitting outside CML doctors' offices....

My recollection was that it was from a Jeff analyst.

I suspect that if HB doesn't offer the info, someone will ask.

I also think that if HB doesn't offer the info, hair on the back of my neck will stand up.

I liked when they noted

I agree this may be in reaction to the warning.

Perhaps, but this Ph I/II isn't pivotal.

Somehow, I thought that the total universe of adverse events that the FDA required to go on the Pona label (including the SAEs that formed the basis for the boxed warning) was from Pona's registration trial.

I suppose we could find out whether the Pona label includes AEs from pre-registration phases.

I guess I assumed that any label warnings would come from the '113 pivotal trial that we expect to start later this year, but I could (easily) be wrong.

According to the clinicaltrials.gov entry, the Ph I/II trial is still recruiting, except for the Scottsdale site.

That was updated as of Jan. 7, 2013, so it's pretty recent.

LINK

However, the most recent updates suggest that they have actually narrowed the criteria, requiring patients to be a bit healthier and to be specifically Crizotinib-refractory rather than "at least one (1) prior ALK inhibitor."

updates

Interesting.

Bodes well for an earlier-than-consensus full enrollment of the pivotal trial.

Yup -- moar new highs!

(After all, we know the crowd is always wrong....)

Just over half the over-allotment got filled.

That sounds to me like they priced this thing to perfection -- cheap enough to sell pretty much all offered, but not so cheap that it all gets taken down as a "no brainer."

Interesting, given the IBanks' general propensity to under-price offerings.

Thanks.

So they only issued 7+% of the over-allotment?

IIRC, the max was 15% -- someone correct me if I'm wrong.

Too true -- aside from "knowing what we own," we're pretty much the mushroom squad.

I think I enjoyed the NVS stand-still discussion more. Can we go back to that?

Well, if we have 13 weeks in Q1 and $2200 per week, then so far, we have:

$2200 x (3 x 12 + 10 x 11 + 18 x 10) = $700,000 for Q1.

If Q1 consensus is $1.5 million, that doesn't bode too poorly.

Run-up started within 2 minutes of your post -- I say you've got some pull with the market!

Ask for some more stuff -- new molecule? pony? universal justice?!

Perhaps Sprycel was €4,353/mo. in 2007?

That would be about US$70,000/year now, allowing for some currency and inflation bumps?

True -- if the fraction is 0.25%, then yes, the cash flow would not be impressive.

Also, true -- the EU number would be half.

But the I'm not sure I agree that not all would be on for the full period. I agree that not everyone eligible would be waiting for approval, but I'd think that most would be. And if we don't think that there is any reason for the over-all rate of growth to be lumpy, then those figures should be even over the calendar -- earlier periods benefiting from pre-approval TKI failures.

Which is to say, if we think that 2500 people in the US would fail other treatments, why wouldn't we expect that population to be extant as of January, 2013?

Either way, I'm thinking that Rachel McMinn's $27 million 2013 sales estimate looks like it could be off by a factor of magnitude....

Yup -- but they say that about every lip-stick-plastered pig on the ticker.

Ideally, with ARIA, it would be more along the lines of "I don't have any for you, and quit calling. Also, tell your friends to quit calling too! ... Now how about some AAPL -- this is a generational buying opportunity! Also CAT! And BIDU."