I certainly hope you're right. We need to reach that $1 to stay on the Nasdaq, and $.80 would be a nice step in that direction after the recent dilution.
The company is in a difficult position with regard to AEZS-130. Without cancer cachexia this is a niche drug. The FDA's insistence on additional trials could be a very expensive proposition.
I doubt if QR Prolongation was even a criteria in the initial trial the FDA agreed to, but they are now concerned with it on nearly all the new drugs being approved. If the company could get them to reconsider the drug with warnings on the labeling to check it, the cost of gaining approval would be slight, but if a new Phase III Trial with perhaps 100 patients or more must be run, it could take years and require at least tens of millions, perhaps more. If that were the case, I might defer development of the drug until I either had a partner, or a revenue stream sufficient to pay for it.
I'm on a drug named Tasigna which has warnings about this. When it was ordered the pharmacist spent a lot of time expressing his concern that I take it seriously. My Oncologist did what was required, but assured me it's not a problem.
The FDA has a problem, they don't care how much time or money it takes to gain drug approval. If one patient in a trial that goes to hundreds of people has a heart problem, they want more testing even though statistically any group that size may have someone with a similar problem, it doesn't matter to them.
Their is a solution, it adds a little cost to the drug developer, and potentially could create great savings for them too. The solution in my mind is Phase IV Trials for every approved drug. The Phase IV Trial would include every patient receiving the drug, and the Dr. administering it would need to report that either their were no problems, or document any problems the patient experienced. The patient would also be given a form that they could use to feed back any information they believed would be useful. The prescription number could be used if the name of either Dr. or patient wished to maintain privacy.
I'm a believer that a lot more drugs should be approved with the Phase IV required for years. The marketplace can determine what's working best, especially where both Dr. and patient can look at the database and decide for themselves what appears to be working. Drug's shouldn't have to do better than the SOC to gain approval, if they show they're safe, that they are effective, let the Doctor's and patients take it from there. The key is transparency. If companies know they cannot pay off and hide unfavorable results, they'll work to find ways to limit them.
Gary
