Risk management is also an area of expertise of mine too - but risk management is not really what we are talking about here. There is an asset that has a fixed life and wasting time also wastes the value of the asset. Every biopharma that I work with puts their emphasis on speed to market because of this fact.
The whole reason for Anavex existing is to commercialize 2-73 and 3-71. Not following regulatory expectations increases instead of decreasing risk that the molecules will be approved by the FDA and EMA. This isn't really even something we can debate because it is fact. Should they have spent more money? Yes, definitely. They have $125m and adding another 200 patients to the P2b/P3 AD trial would have cost...another $20m? NBD. Doubling the size of the Rett trial - as they admit themselves they should have done - would have cost another...$10m? NBD. The voucher was worth $100m. A successful outcome would have been worth $30-$50 per share.
In biopharma operations you have risk assessments like FMECA, HACCP, HAZOPs, maintainability and operability, etc. but risk assessment here is simple: you need to conduct the right size and number of trials and Anavex did not do this - and I don't know of ANY other biopharma company that chooses this path. They increased their risk by not spending on mandatory choices. Pure hubris. But, I think they are learning now - at the ASM they described how flawed their approach was and how they will rectify it (of course they also told us they would announce Rett direction that very weekend at the Rett conference in Denver, but didn't, so...)
You might make the case that they didn't know so they didn't go all in. But they represented to us (buyers of shares) that they were committed to succeeded - not that they were semi-committed and hedging their bets. I bought in whole-heartedly because I believed (still believe) that their programs can bring huge value and generate great returns for shareholders - so the company being less committed to their own premise than me is disconcerting. We are betting on them to be committed, not to simply keep the Anavex lights on as long as possible.
This company has access to capital and use it all the time. There is not a zero sum game. Not using the capital for the purpose we are invested is wrong.
Anyway, I hope all of us see Anavex put the pedal to the metal and accelerate programs through to approval. Spend our money and give us a return! LFG!!!
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