Overview: FDA IND vs NDA
I have seen some confusion around the terms; hopefully this can help understand the investment implications.
An IND submission is when a company has completed (at least the minimum) required animal toxicology and safety assessment [preclinical] studies and are seeking FDA approval to start safety assessment trials in humans [Phase I]. Approval is not dependent on whether they think the drug candidate is effective, only if the drug has been shown to have a low enough risk profile to begin safety testing on humans.
An NDA submission occurs when a company has, in their opinion, successfully completed all phases of clinical trials. (Phase 1 = safety, Phase 2 = effective in small sample sizes, Phase 3 = drug is statistically significantly more effective than placebo in large sample sizes) and seek to put the drug on the market. This is an orders of magnitude more comprehensive review vs an IND. Once approved, the drug can begin to be sold and compete on the open market.
There is also an after-market data collection period (sometimes called Phase 4) wherein if enough adverse events are reported (either ones not seen in clinical trials or ones the company didn't report) the drug can be pulled off the market.
Personally, I would also advise to treat any investment into a small biotech company as speculation. Around 80-90% of drug candidates never make it to market. Small biotechs often exist only to bring ~1-4 drug candidates to market and fold if none succeed. They are intended to burn through cash and don't have any internal R+D structure to supply new drug candidates.
For more information, I have included this infographic and more specific information can be found on the FDA's website.
There is also an after-market data collection period (sometimes called Phase 4) wherein if enough adverse events are reported (either ones not seen in clinical trials or ones the company didn't report) the drug can be pulled off the market.
Personally, I would also advise to treat any investment into a small biotech company as speculation. Around 80-90% of drug candidates never make it to market. Small biotechs often exist only to bring ~1-4 drug candidates to market and fold if none succeed. They are intended to burn through cash and don't have any internal R+D structure to supply new drug candidates.
For more information, I have included this infographic and more specific information can be found on the FDA's website.
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Investing primarily in bio-tech and drug development; both big pharma for growth and start-ups for speculation
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