Hi SFWolf,
This is where I share XenaLives opinion. The current formulation of the drug gives certain advantages for a phase 2b trial. With an IV formulation you know for a fact drug is being delivered and you can get very accurate blood/PK levels. This provides crucial information on pharmacodynamic data - i.e. what level of drug in the blood correlated to what level of clinical improvement. There is still the mystery of how much of the drug is getting into the brain, but I assume they have some data on this as well.
To go to a Phase III is very difficult with this setup. The reason they only have 6+3 patients is because it is extremely expensive to do IV drug studies which tend to be done as an inpatient with nursing support, monitors etc. If they are unable to make an oral form of the drug, you are multiplying the IV infusion form of the medication x placebo/drug group x at least several weeks. So you can see the cost factor scales up significantly.
Having an oral form for example, greatly reduces costs (and complications) however, you now have to start from scratch on figuring out bioavailability of the drug etc. If the IV numbers say that you need a very high dose of the medication to achieve a clinical result, then they may be SOL if the oral form can't achieve this without extremely high doses which will likely cause toxicity.
So you can see the quandary that they are in. My guess is that they have a good product, probably even efficacious, but the delivery of the medication is causing some headaches. No one wants to spend 10x the amount on a phase III trial when the final product ends up being a hospital/nursing home only infusion therapy which will be cost prohibited. They are probably looking at other forms - i.e. intramuscular depo, pump delivery etc, but none are as easy as oral form. My guess is that they are screening their "bryolog" compounds library to find another hit, but even if they find one, they have to really start the process completely over - as there might be thousands of these with different toxicity profiles.
i could keep rambling but hopefully this gives you a sense of what the internal dialog is like.
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