He may be right, he may be wrong, but he sounds like a grade a, self aggrandizing no nothing nit wit. Not to rely on ad hominem, but his little rule is stupid tripe. In the sector a vast majority of companies fail in the manner his rule states that a subset will based on something that is actually arbitrary. The fact that they are under $300 million means that the understanding of the process involved is well known in many cases. What is the opposite of "rare on rare", Oh, the R-F rule! What he shows clearly in this article is that he is basing NONE of his prediction on any actual knowledge, but is relying on derivative collective knowledge gleaned from the market. Does he actually make a living doing this? The "R-F rule.' He should really think about making a significant contribution before beating his chest. Lets say that he is correct and the patient population being given DTIC for 2 years is actually pushing out the KM curve out this far because the are healthier stage III an IV patients with unresectable disease. How many in the treatment arm would be alive if A7- has no therapeutic effect? It s in no way a benign disease, especially after it has spread locally. If you have around 260 randomly selected patients at this stage of their disease and left them off treatment for two cycles of snake oil, there should be enough events, and if you take 130 patients, a majority of them who have still evolving distal mets, and treat them with a toxic alkylating agent, I find it hard to believe that their survival as a group would be what it has to be to support Adam's statements because they had a mild case of stage IV melanoma and will be out of the office for the weekend. A-7 is a completely novel approach, IMO, 'the market' cannot possibly know what it's mechanism is and whether it would be successful or not based on the paradigms they are used to.
The fallacy in this is that 3 FDA safety checks over 4-5 yrs occurred in which a minimum of equivalency is present between the 2 groups. DTIC has been shown to extend OS in melanoma, therefore at a minimum A-7 has some effect in extending OS on average. In no way can AF state that a-7 is ineffective as a melanoma tx without looking at the trial data. With a very benign safety profile it has a place in the oncologist treatment options particularly with senior citizens.
There were more than 3 safety checks, as far as I understand. Safety checks were conducted every 6 months starting within a few months of the initiation of dosing in early 2007, until the last person was dosed in Feb 2012.
AF has done practically ZERO due diligence on A-7....
He will get his just deserves...
And I will call him up personally, since I spoke with him a few years ago on a few occassions, to point out what a little putz he is.
Your post is spot on regarding the benefit for A-7.
AF fails to mention that the SPA ( special protocol application ) with the FDA that VICL negotiated is 90% powered to meet the primary endpoint for a durable response rate after 24 weeks of treatment and the secondary endpoint of median overall survival in the subset of metastatic melanoma patients free of liver and brain metastases who are sicker and older than the phase 2 trial of high dose A-7.
The modified RECIST criteria to give at least two cycles of A-7 to patients to see the beginning of a durable response is another point that A.F. does not mention.
The trial design was specifically crafted to demonstrate that the A-7 phase 3 trial will succeed on both endpoints.