Following are my notes, in very rough form.
I'm very excited still, but very conscious that an investment here assumes that company guidance for 12 month placebo median PFS is correct. More precisely, it appears that anything up to about 17 months placebo PFS would give great odds at interim, which is 40% worse than guidance! So I am comfortable with such risk, but others need to decide for themselves.
26.6M shares OS, $21.4M cash, Q burn was 6.9M (will slow down somewhat - Q3 was high for HEAT milestone payments)
Acknowledged that burn will decrease slightly simce "hump" of HEAT costs are over in Q3.
380 events "possibly as early as q412".
HEAT enrollment extended to 700.
[me - was 640-650 to allow China to be registrational.]
later in QA acknowledged that 700 will get them to 380 events quicker
No OS (overall survival) bar is set at interim - it is "totality of the data".
Cash should last through 2012 [me- although this would reduce us to scraping the barrel again - doubt they'd go past 2q12]
S Korea and Taiwan are registrational in size, China [believe he said Taiwan in the call, but misspoke] is "quickly approaching" 200.
Japan PMDA still reviewing but no action. Yakult in charge of details of new trial and approach.
ABLATE - data should "closely follow" the approval of TDox. [assuming company guidelines]
Gross margins should be 90%+
SPA says if interim hit FDA would need to be consulted. No specific process.
If only a continue, co guidance is that DMC will only relay that fact. NO EXTRA DATA.
Well placed in terms of competition on horizon.
Co. gets "standard set of data" after continue - but pooled, not broken out per arm - it is still blinded!
No saying when DMC meets or when 190 happened [except we know 190 in 3q11 from the 8k filing. my best guess still second week of Aug '11]
Will not disclose p-value needed at interim. Can figure lots of stat data from that - not fair to all shareholders.
Went to 8-10 weeks for processing data... [believe this incorporates taking "extra care" with data into account w/ the increase over prior 6-8 weeks given]
Not substantially more than 190 events, but included a "safety margin".
Licensing talks continue.
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3 comments:
So do you think they'll have a result before end of the year?
Just out of curiosity, do you think second week of August because that's when all the insider buying seems to have stopped?
I definitely think we'll have the results by the end of the year.
Company said on the conference call that the 190th event happened in Q3 - and that results should take 8-10 week. That would be 12/9 at the extreme end of that guidance. We are now six weeks into the 8-10 week period, and you would not think they'd be too far off being IN the period. My updated guess would be 11/25, but I think Thanksgiving week would interfere... so I'm now calling for results by 12/2. Of course, we could hear Monday!
Forgot the second part of your question. I no longer think second week of August was the trigger, because we're 13 weeks past that - and updated guidance is for 8-10 weeks!
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