So, Ariad's going to only test T315i mutation patients, in a single-arm cohort, non-randomized trial? Are you suggesting they are going to have a trial similar to Omapro's < 100 patient trial? If so...how well did that go for Omapro? Not only that, can you tell us your projections for revenues on such a patient population?
Well. We all know that Ariad is going to be testing T315i and all other mutant variants of CML/BCRabl, and resistance to currently approved TKIs for CML.
Gleevec v. Tasigna recent trial: 220 sites and 846 patients.
So, I would highly doubt Berger would be doing a trial of less than 100 patients like Omapro, unless he wants to run into the same problems they are now. And, Ariad doesn't need to do a 1,000 patient trial.
So, what do you think the trial will be designed as in a likely SPA agreement? Here's a likely scenario: 300 patients global; 30-50 worldwide sites. Cost: $20- $30 million. If you don't already know, clinical trials always run over first cost analysis. (Take a look at SUCCEED).
$20 - $30 million. And you think Berger can "go it alone" or come "very close to approval" without either a partner or doing another dilutive financing??????????? They had year end guidance at $44 million.
You can't assume guaranteed funding from Merck from milestones because all those are dependent on many different factors, so, a prudent management team/Board wouldn't be using those as a guaranteed cash flow:
$44 million - $30 million ('534) = $14 million (BTW, Ariad has a loan agreement with a local bank which states their cash position must be held above ~$13 million).
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You don't think for one second that every I-Banker out there right now is telling biotech CEO's, "second half is going to be rough. Double-dip. Solidify the cash balance now, etc. etc." It's slimey sales tactics from the banks, but CEOs buy into it time and time again.
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IMO, the smart thing for Harvey to do is partner '534 sooner than the pivotal trial, and have the muscle to move '534 into solid tumors and other indications like AML, etc. With their current cash position, they can't do that, without financing (partner or dilution).
So let's here your bold prediction about how much a trial will cost.
Does Ariad have less than a $1 billion market cap? Hmmm. That would make it a small-cap stock, now wouldn't it.
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