Replies to post #353193 on Bioelectronics Corp (BIEL)

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1. The FDA application itself (just the filing)

* Filing a new drug application with clinical data: about $4.3 million
* Simpler applications (no clinical data): roughly $2 million

This is the direct cost paid to the FDA.



2. Clinical trials (the big-ticket item)

* Phase 1–3 trials combined: roughly $400M–$500M+
* Some estimates range $500M–$2B depending on complexity
This is usually the largest real expense.



3. Total cost to get a drug approved (full picture)

* Conservative estimates: ~$700M–$1.3B
* Industry estimates (including failed drugs & time value): up to $2.6B+

Why so high? Because:

* Most drugs fail before approval
* Companies must cover all failed attempts too

4. What about generics or simpler approvals?

Much cheaper:

* Generic drug application: about $100K–$300K+ in fees
* Minimal or no large clinical trials needed

So what’s the “real” answer?

* Bare FDA fee: ~$2M–$4M
* Typical total program: ~$500M–$2B+
* Full industry-adjusted cost: up to ~$2.6B

Big takeaway

When people say “FDA approval costs billions,” they don’t mean the paperwork—they mean everything required to earn that approval (research, trials, failures, time).

‘Nuff said!




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