Let’s take the scenario of a company with an epilepsy agent and they have quality Phase 2 studies (the actual pivot point to move forward with approval).
The Phase 3 studies will cost millions of dollars and must be accomplished in many clinics and countries for international and US approval.
This is the first of many decisions, will the product be approved based upon these studies?
Will it have enough efficacy data to demonstrate insurance and agency approval?
If all of this above information is convincing to agencies, there is certainly discussion among the initial venture capital investors who want a return on investment.
Certainly, given today’s economic tightness an acquiring company will ask for as little money as possible and wait out the approval to verify clinical study results.
This means the investors are anxiously awaiting study results and their money gets tighter.
If the decision is made to be acquired, historically this means your company no longer exists as an independent entity.
You will receive a positive payment for your life’s work, it is now handed to another entity.
The alternative is you forge forward with the expected product launch. If this is the case, then you need a chief commercial officer and other top line leaders to organize commercialization. This means more money invested until agency approval.
Once approval happens, the overall company headcount needs to be anticipated and with it the budget.
There’s Medical, Marketing, Sales, Market Access, Logistics, Distribution and a limited distribution network (saved for a separate conversation).
An anticipated budget for first year is $75 million Euro.
This means at a minimum, net sales of $100 million Euro.
Neurology Life Science Consulting
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