When I read that it takes $ billions to get a drug FDA approved and 1 drug in a 100 gets approved I am not encouraged. Those are not the real issues for this company.
For a low-tox, topical drug like herpecide, with immediate results observable, the cost to take it through pre-clinical, human clinicals and regulatory approval for 1-3 indications (HSV-1, HSV-2, VZV) will likely only be $70-100 million. That "billions" thing comes from a very flawed study attempting to justify the cost of drugs today, and includes Marketing, SG&A, failed drugs (including failing drugs that managements push along to keep the share price up), etc. I cringe whenever management benchmarks their performance against that study. It's rather disingenuous, IMO.
Allow me to recommend a book that puts things into perspective: New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients
And as for the 1% odds, it's closer to 14% according to a recent MIT study: labiotech.eu.
Our odds, if we can get our drugs into human trials, are going to be much, much higher if we don't screw up our clinical test and submission strategy and paperwork. |
