Richard and Miljenko took a crack at your previous comment, but I'll address stuff they didn't (which I either agree with, or in the case of FDA officials, can't comment):
It also frankly destroys any incentive to develop improved products for all buy life threatening diseases.
Should a company be wasting it (or its shareholder's) cash on drugs for non-life threatning conditions that are only an epsilon improvement? If the previous treatment was proven safe for (in the case of allergies) millions, then how could you justifiably approve a drug with only incremental improvements when there is a substantial risk of future complications? Especially considering the other allergy drugs pulled due to QTc complications?
and had trial results that werer virtually flawless.
What's more dangerous is what they didn't publish in the papers.. also, I don't know if this is significant, but the animal data. I'm kind of getting out of my realm here, but basically I'm asking how somebody could determine (except SEPR insiders) if the trial was 'flawless'?
Let's consider for a moment that Soltara is truly safe; SEPR does another clinical, submits the data, and the product gets improved. The drug gets out in society, and the FDA has fufilled their role in making absolutely sure that the incremental gain in efficacy is associated with a reasonable assurance that the drug is just as safe as the drugs that soltara is trying to replace. The only loser in this game would be SEPR's stakeholders. The rest of society wins.
And since there's nothing you can really do about it, the next time around, you either thouroughly design the trial perfectly (which costs big money), or you develop drugs that have greater incremental gains in efficacy.
Do you have allergies. Claritin is a friggin sugar pill.
Spring hayfever. Although it was worse when I was younger. Claritin is crap, agreed. Personally, I liked Seldane.. tasted like minty spit, but worked really damn well. And I haven't died of a heart attack yet. Maybe I can launch a class action lawsuit for potential future cardiovascular complications.
Increasing the cost of drugs is of benefit to no one.
It's to the benefit of shareholders in companies selling patented products that other companies don't have the resources or intellectual capability to develop. There are always winners in the game for any given condition.
And in a way, it's also to the benefit of the consumer. Imagine what crap there would be out there if there was no such thing as a double-blinded clinical trial? Would you be willing to bet your life on IMC-C225's Phase II data? Didn't think so.
The fact that so many companies are getting rejected after submission is clear evidence of a major problem.
Did that prevent IMCL from doing what it did? Also, the sign that so many drugs getting rejected could perhaps be a sign that companies are willing to take shortcuts in preparing their data, and sloppy clinical trial design. The onus is on the company to prove safety and efficacy, not the FDA's.
On the issue of "Biotech valuation", the great thing about this sector is that companies which survive the process are rewarded handsomely; our job as investors are to find ones that will pass the FDA and have as many people as possible betting against them when your bet is made... now that plenty of people are betting against SEPR, the real valuation questions here are: Is SEPR going to get another crack at the FDA with Soltara? Will they be able to cough up $400M in cash by the end of 2005? |
