The God Molecule Countdown: T-31

Is the God Molecule (i.e. next Ariad molecule) a "Third Generation" TKI?

A strong medical need still exists for better tolerated therapy to treat NSCLC patients harboring EGFR mutations. Here we report the discovery and development of a potent third generation, irreversible mutant-selective EGFR TKI that is expected to improve/maintain efficacy on oncogenic EGFR mutant patients while demonstrating reduced side effects. EGF816 potently inhibits both activating (L858R and Ex19Del) and T790M resistant mutations in various cellular assays; it is selective against a large panel of kinases in both Ambit and BaF3 profiling, and more importantly is selective against WT EGFR. EGF816 is efficacious in mutant EGFR-driven xenograft models, is well tolerated in IND-enabling toxicology studies, and is entering phase 1 trials.

The God Molecule Countdown: T-32

Will it be KRAS related?

If so, that would be profound and we would quickly be to 30.

KRAS

More to follow. Watch this space

TC

God Molecule Countdown: Day T-34

Here we go.  Reason 1 to love the God Molecule - This one from Jesspro on iHub.

Ariad's probable advantage with the New molecule is that, during clinical trials, its performance will likely be compared to placebos as there - this because there are no current treatments for "unmet medical needs,"  which is how Ariad has described the purpose of this new molecule.   As a result, even a modest advantage in the trials over placebos maybe considered successful.  Furthermore, once P1 and P2 have been completed, and if they are successful, accelerated approval could follow. Unlike 113 and pona(CML), which had to  compete with existing therapies,  the Nmole development may not be as expensive and could advance more quickly. 


 Note: The following is from Kendra at Ariad IR regarding the God Molecule

Kendra Adams <Kendra.Adams@ariad.com>	Sep 30
to me

We have communicated that we expect to nominate our next development candidate by year-end.

Regards,

Kendra

Countdown to GOD MOLECUE - SHORTS BEWARE!!

COMING SOON.

The GOD MOLECULE, Ariad's new "Best in Class" product is due out before the end of the year.  I have written to Kendra Adams, Director of Investor Relations, and she has CONFIRMED that there will be an announcement before the end of the year. CONFIRMED.

This means...as of December first, we have 30 days until the GOD MOLECULE is unveiled.  And when it is....expect a significant increase in PPS, or perhaps a buy out.  My prediction is that, when this happens, we'll be at at least 10.  

more to follow....on what it is, what the market will look like, and what this will mean for Ariad.

TICK.  TOCK. TICK. TOCK

TC

What Dr. Strangelove is Afraid to Tell You About AP26113

This one, Dr. Strangelove, is for you.

1. AP26113 is an amazing molecule by all accounts, and has tremendous life saving potential. 

2. It is one of only 58 molecules (57, but let's not get into that here) that has been promising enough for the FDA to elevate to Breakthrough Therapy status (many applications have been rejected). 

3. Not only is this reason for hope on the part of cancer patients and their families is potentially game changing for Ariad and it's investors (and count me in). Revenue in YEAR ONE of approval could be on the order of 350m, this based on CURRENT crizotinib sales...and that is for just one indication. 

4. There is now evidence to suggest additional indications for AP26113, thus the potential for multiples of crizotinib revenues. 

5. Given the FDA's rules for approval under breakthrough therapy Designation, and the experience with other molecules previously given BTD, approval could actually happen as early as JANUARY OF 2015. 

6. And here's my favorite...only a madman would initiate a short position against this equity, and I am confident that those currently stuck holding such positions are frantically looking for an exit ramp (which may explain some of the irrational posts we have seen cropping up on various boards lately). 

Kind regards to all, 

TC

When will AP26113 get FDA Approval?

AP26113 Will probably get FDA approval sometime around August of 2015.    This guesstimate is based on the mean number of days that 14 drugs which have received  FDA Breakthrough Therapy Designation (BTD) have taken to receive FDA approval.

That said, given the history of drugs that have previously received  BTD,  AP26113 could conceivably be approved  as early as January 2015.  This guesstimate is based on the fastest movement from BTD to FDA approval, which was 82 days (Eltrombopag: BTD on 2/3/2014; FDA approval on 26-Apr-14).

On the other hand, it might be as late as March, 2016.  This is based on the slowest movement (531 days) fromBTD to FDA approval (Ibrutinib: BTD 2/12/2013 FDA Approval 7/28/2014)

Breakthrough Therapy Designation Table          (Source for table)

So, now the disclaimers...

1. Double check my math (it's late, I'm tired, and...seriously, help me out here).

2. There were 58 drugs approved (one list says 68, but I'm only counting 58), and of these...14 have have been approved: I have NOT counted the days that unapproved drugs have been waiting for approval, so someone might want to calculate new intervals given these "not yet approved" drugs. I have treated FDA Approved and "NOT APPROVED" as apples and oranges because, well, see point 1 above.

3. Yes, I get that every drug is different and the path for one drug's approval need not predict the path of another. As such, who the heck knows when AP26113 will get approved....I'm just giving a RANGE of possible approval dates IF it gets approved.

4. And, yes, it may never be approved. There's no guarantee whatsoever the "BTD" leads, without fail, to FDA Approval.

Looking forward to your comments and quibbles.

Trading Cyclist.

Hark, The Angels Sing

or not.

The end is in sight. We're up and away and the fours and fives and soon the sixes will be gone for ever and ever because, well, the angels sing.  And sing and sing and sing.

And sing they do, the boards are all aglow with Christmas cheer.

And not only that, 2Da  and BR are on the run. (Thank GOD!). So, hark the angels sing - we're up, we're out of the woods!  And I should feel absolutely just fine about putting way, way waayyyyy too many eggs in my pretty new Ariad basket.  As only a fool could weight down a single financial container.

Yup. We're up. And we're confident. And we're giddy with our prospects and the hint, lo, the promise of a happy ending before too long. Or soon even.

But, amidst all that that singing and rejoicing I paused and, heaven and angels forbid (and forgive me) took a minute to look at the PPS over the last six months or so.  And we've been here before. At least four times. Who knows what happens next. Or when.

Be safe.

TC