Who's Your Daddy?

Who to believe?

In one corner, we have....

• Otsuka
• Denner
• Blackrock
• Fidelity
• Other Tutes
• The FDA (giving AP26113 BTD)
• commercial agents throughout Europe, Eastern Europe, Asia (see above) and of course Australia
• Docs and patients who went to bat after the debacle
• Science (just peruse prior abstracts from publications about Pona, 113 etc....multiple indications, impact, efficacy...and, yes, learning how to manage the risk/benefit trade off).
• A logical plan about the strategy for growing the company, and a conservative scenario of $400m revenues in 3 years.

And in the other corner, we have...

• Daily bashers (shorts in long's clothing?)
• daily market fluctuations
• bitter investors that didn't sell when we were at 20+ (not that I can blame that, it's just them emotion clouds one's judgement). 

So, who's your daddy?

GLTA

TC

BOOM!

God molecule going to clinic, partnership on AP26113.  Read all about it!

Press release

A P 26113 Approval In February...or more likely July?

Looks like approval might come earlier than we thought. 

Here is a recent  article which estimated time from BTD to approval at four months.  

BTD approval speed

However, I did the math, using data published on the FDA web site (FDA) as well as press released from individual Pharma companies re BTD announcements.  I found that the average days to market was 235, or roughly 8.8 months.   That would suggest an AP26113 approval date somewhere around July (my estimate in a prior post was August, so not much as changed).   However, as I noted previously, the approval can be as fast as 55 days (Amgen's Blincyto), or as long as 498 days (Merck's Keytruda)  

Hang in there everyone. 

TC

God Molecule Coming Wednesday: update

What would happen? 

First of all, this could happen. The molecule has been nominated, which was an internal corporate event. Investor relations (Kendra) has also been clear that they would share the profile of the molecule at an appropriate public event.  So go figure.

• God Molecule nominated. Check.
• Biggest healthcare conference of the year is happening next week. Check. 

There isn't a better time to unveil The God Molecule.  And when they do, and if it is good,  it will be an extremely interesting day. Big Institutional investors will want in.  Shorts will be trapped at the exit. And the outcome could conceivably be a 100% plus increase in share price.  

UPDATE:  I wrote to Kendra at investor Relations and asked her to confirm if the internal nomination for the new molecule happened.  Her reply was that "She encourages that [we] listen to the webcast at the JP Morgan conference for a full update." 

This is not a good time to sell.

Good luck to all.

TC

AP26113 Approval could come at any time based on existing data

Short Version of the Story: Ceritinib received FDA Approval based Phase One Trail data that was that was inferior to AP26113 Phase I/II data. As such, FDA approval for AP26113 could come at any moment, and the FDA might not wait for results from the Alta Phase II trial (for which recruitment is now underway).


Long Version of Story...

First of all, things can move quickly.  Let's take the Ceritinib, which received FDA Approval based on PHASE ONE trail data.  Here's the language about that data.

In April 2014, the next-generation ALK inhibitor ceritinib received an accelerated approval as a treatment for patients with ALK-positive NSCLC following progression on crizotinib. This approval was based on phase I data from the ASCEND-1 trial showing an overall response rate (ORR) of 58.5%. The early median duration of response was near 7.5 months - See more at: http://www.onclive.com/peer-exchange/nsclc-needs/Next-Generation-ALK-Inhibitors-in-NSCLC#sthash.g9PjxxjH.dpuf   Source 

Now, let's compare that to the AP26113 Phase I/II Trial Data Results (and note it's phase I/II, not just phase I):

The objective response rate (The objective response rate (ORR) in 72 evaluable patients with ALK-positive NSCLC was 72%. The median duration of response was 49 weeks. The median progression-free survival (PFS) was 56 weeks. In the 65 evaluable patients treated with prior crizotinib, the ORR was 69% with a median PFS of 47.3 weeks.  In 7 evaluable patients with treatment-naïve ALK-positive NSCLC, AP26113 demonstrated 2 complete and 5 partial responses, for an ORR of 100%. In patients with untreated or progressing brain metastases (n = 14), 71% of patients had evidence of radiographic disease improvement. - See more at link     

Now, you do the math.   AP26113 has better clinical data than a drug that the FDA recently approved based on Phase I Clinical Data.

The punch line is that AP26113 Approval could come at any time.