Skip to content

Investment Resources

  • Blog

Kyle Dennis FDA Insider Alert | 5 FDA Terms You Should Know for Trading Biotechs

July 16, 2019 by John Gladston

If you don’t know, I didn’t start to make real, life-changing money until I starting scaling up on my biotech trades. Over the years, I’ve been able to understand what moves biotech stocks… and a lot of the times it’s due to a catalyst event.

However, when you’re first starting trading biotechs… you might be overwhelmed by all the information thrown at you. You see, biotech companies use their own lingo… and if you can understand what they’re saying… then the profits should follow with.

Now, there are specific terms that let me know whether a trade will be good or not… and I focus on those solely.

There are 5 terms that you should know if you want to start trading biotechs:

  • Phase I / II / III trial
  • New Drug Application
  • PDUFA
  • Form 510K
  • Advisory Committee Meeting (Adcomm)

Table of Contents

  • 1 Clinical Trials
    • 1.1 Form 510(K)
    • 1.2 PDUFA
    • 1.3 New Drug Application (NDA)
    • 1.4 Advisory Committee Meeting (Adcomm)
    • 1.5 Related

Clinical Trials

Before biotech or pharmaceutical companies market their treatments to consumers, they have to go through a grueling process. One of those processes is clinical trials.

Now, clinical trials are typically split up into three stages: Phase I, Phase II, and Phase III (sometimes you’ll see a Phase IV, but it’s not that common).

A Phase I trial is the first stage of the clinical trial process. In this stage, the company typically conducts a dose testing trial conducted in healthy volunteers. In other words, they’re testing their treatments in healthy volunteers.

Now, the end goal of this trial is to determine the maximum tolerable dose in healthy humans. In this trial, the company tests the treatment to determine how the human body metabolizes, in other words, removes the treatment from the body.

Additionally, they’ll test the treatment to see whether it’s safe, how tolerable people are to it, and whether the treatment works.

If the company gets the okay to move onto a Phase II trial.

In the Phase II trial, a small patient population would be used to determine the safety, and sometimes the efficacy, of the treatment.

Now, the Phase II trial is divided into Phase IIa and IIb, sometimes. A Phase IIa trial is primarily conducted in figure out the dosage for patients. On the other hand, a Phase IIb is used to test the initial efficacy (how effective the treatment is).

If the company moves onto the Phase III stage, there would be a large scale, full-fledged, and often pivotal, trial to test the treatment’s efficacy and safety. In other words, the Phase III clinical trial is conducted to confirm the effectiveness, monitor the side effects, as well as compare the drug to other commonly used treatments.

Now, this might all sound a bit confusing at first… but it gets easier. You see, all really have to do is see whether the data release is positive or negative.

For example, I actually made $5,600 on a biotech stock that released positive Phase I / IIA results recently.

You see, the company actually noted the treatment was effective and “detected immune responses to 93%…”

Here’s a look at the press release.

Not too long after, I spotted a buying opportunity… and with good data just a few weeks prior to when I got in… it could still run higher.

(Looking for biotech alerts? Click here to receive alerts to trades like this one in GNCA… in real-time)

Now, once I spotted my setup, I had my stops and targets in place… and was able to lock in $5,600 in just 1 day.

(If you want to learn how to profit from biotech stocks, click here to find out more about the strategy that turned me into a millionaire)

Moving on.

Another key FDA term to know is Form 510(K).

Form 510(K)

Now, the Form 510(k) is a premarket approval notification. This form is generally filed by manufacturers of a new medical device if the device is “substantially similar” to an already approved device, which also did not require a premarket approval form.

However, as regulations have become stricter, the FDA has started asking for more and more data for the 510(k), making it almost equivalent to an early approval form.

When a company gets 510(K) approval, that’s really bullish… and you can actually spot plays from that.

Why?

Well, if they’re approved, they move closer to being able to generate revenues and earnings from the product… which causes the stock to run up, as traders price this in.

I’ll often look to see whether companies have upcoming 510(K) approval dates, pair it with a bullish chart pattern, for the catalyst runup.

(If you want to be a part of FDA Insider Alerts and receive my biotech and pharma watchlists, as well as real-time alerts and so much more… click here to take advantage of the 80% discount NOW)

Moving on, the next term is an important one. It’s the Prescription Drug User Fee Act (PDUFA)

PDUFA

PDUFA is both a law and a procedural step. Now Congress passed PDUFA, which allows drug sponsors to pay the FDA a fee to study their New Drug Application (NDA)  and approve or reject the drug candidate.

Now, as a procedural step, it is the particular day on which the U.S. Food and Drug Administration (FDA) makes this decision, and it’s one of the most important catalysts in the premarket lifecycle of a drug candidate.

Basically, this is known as the FDA approval date. If the treatment gets approved… then look for the stock to gap up… if it isn’t approved, well… the stock will probably drop.

Again, this is another term that I look for and pair with a bullish chart pattern… and let my clients know my exact plan.

Now, I actually mentioned the next term just before when I was talking about PDUFA.

New Drug Application (NDA)

The NDA is an application made by the sponsor of a drug candidate to the FDA before or during the Phase III trial.

The primary goals of an NDA are to determine whether the treatment is safe and effective and if the benefits of the treatment outweigh the potential risks.

Basically, the NDA should provide the FDA with enough data for it to determine if the proposed labeling is appropriate and what other information it should contain. Moreover, there should be data that describes the manufacturing methods and quality control.

If the NDA is approved, the sponsor can market the drug in the U.S. On the other hand, the application could be rejected outright. However, this is quite rare. The FDA could also ask for more data, or another trial, or for further clarifications.

Advisory Committee Meeting (Adcomm)

An Adcomm, or Advisory Committee meeting, is often summoned by the FDA a month before the PDUFA and consists of a dozen or so outside experts, a patients advocacy representative, and a non-voting industry expert.

At the end of the discussion, they vote to approve or reject a drug. This decision is non-binding for the FDA, but is often indicative of the PDUFA decision.

That said, it’s critical to know when adcomm dates are, especially if you’re trading biotech stocks. For example, if the meeting vote was a clear cut “No” that tells you to shy away from buying the stock until there’s another potential positive catalyst.

As you can see, understanding these terms can help you uncover opportunities in the biotech and pharma stocks. Now, if you’re ready to find massive catalyst trades in these stocks, then take advantage of my FDA Insider Alerts today.

[Ed.note: Kyle Dennis runs BiotechBreakouts.com. He is an event-based trader, who prefers low-priced and small-cap biotech stocks.

To learn more JOIN THIS SPECIAL ONLINE EVENT: 3-Step Plan Kyle Used to Turn $15,253 into $2,855,475 and download his FREE “The $2.9 Million Biotech Trader Playbook here!]

Source: BiotechBreakouts.com | Original Link

Related

Categories Kyle Dennis Biotech Breakouts Tags $100k Heist Live Event Kyle Dennis, $100k Heist Webinar Kyle Dennis, $100k Heist Webinar Registration Page, $100k Heist Webinar with Kyle Dennis, Biotech Breakouts, biotech breakouts kyle dennis review, biotech breakouts login, Biotech Breakouts Review, Biotech Breakouts reviews, Biotech Breakouts scam, Biotech Breakouts Stock Alerts Service Review, Biotech Breakouts Stock Alerts Service Scam, Biotech Nucleus, Biotech Nucleus Cost, Biotech Nucleus Customer Review, Biotech Nucleus Good, Biotech Nucleus Kyle, Biotech Nucleus Kyle Dennis, Biotech Nucleus Legit, Biotech Nucleus Real Member Review, Biotech Nucleus Review, Biotech Nucleus Reviews, Biotech Nucleus Scam, Biotech Nucleus User experience, Black Optics Review, Black Optics Reviews, Black Optics Scam, Black Optics Trading Program, Black Optics Trading Strategy, Black Optics Trading System, FDA Insider & Lightning Alerts, FDA Insider & Lightning Alerts Kyle Dennis, FDA Insider & Lightning Alerts Review, FDA Insider & Lightning Alerts Reviews, FDA Insider & Lightning Alerts Scam, FDA Insider Alert Free, FDA Insider Alert review, FDA Insider Alert reviews, FDA Insider Alert scam, fda insider alerts, Fortune Forecaster, Fortune Forecaster Complaints, Fortune Forecaster Discount, Fortune Forecaster Fraud, Fortune Forecaster Login, Fortune Forecaster Performance, Fortune Forecaster Price, Fortune Forecaster Real User Review, Fortune Forecaster Refund, Fortune Forecaster Results, Fortune Forecaster Review, Fortune Forecaster Reviews, Fortune Forecaster Sale, Fortune Forecaster Scam, Fortune Forecaster Stock Gumshoe, Fortune Forecaster Strategy, Fortune Forecaster Strategy Review, Fortune Forecaster Strategy Reviews, Fortune Forecaster Strategy Scam, Fortune Forecaster Website, How to turn $5K into $100K, How YOU Could "Steal" $100k From Wall Street, I.G.N.I.T.E., I.G.N.I.T.E. Options Kyle Dennis, I.G.N.I.T.E. Options Strategy, I.G.N.I.T.E. Options Strategy Kyle Dennis, I.G.N.I.T.E. Review, Join The Heist, kyle biotech breakouts, Kyle Dennis, Kyle Dennis Black Optics, Kyle Dennis Black Optics Complaints, Kyle Dennis Black Optics Fraud, Kyle Dennis Black Optics Login, Kyle Dennis Black Optics Performance, Kyle Dennis Black Optics Program, Kyle Dennis Black Optics Refund, Kyle Dennis Black Optics Results, Kyle Dennis Black Optics Review, Kyle Dennis Black Optics Reviews, Kyle Dennis Black Optics Scam, Kyle Dennis Black Optics System, Kyle Dennis Black Optics Website, Kyle Dennis FDA Insider & Lightning Alerts, Kyle Dennis FDA Insider & Lightning Alerts Review, Kyle Dennis FDA Insider & Lightning Alerts Scam, Kyle Dennis FDA Insider Alert review, Kyle Dennis fda insider alerts, Kyle Dennis fda insider alerts review, Kyle Dennis fda insider alerts scam, Kyle Dennis Fortune Forecaster, Kyle Dennis Fortune Forecaster Review, Kyle Dennis Fortune Forecaster Reviews, Kyle Dennis Fortune Forecaster Scam, Kyle Dennis lightning alerts, Kyle Dennis lightning alerts review, Kyle Dennis lightning alerts scam, Kyle Dennis review, Kyle Dennis scam, Kyle Dennis Stocks, Kyle Dennis Stocks review, Kyle Dennis Stocks scam, Lightning Alerts Free, Lightning Alerts Review, Lightning Alerts Reviews, Lightning Alerts Scam, Middle-Class Millionaire Kyle Dennis, Middle-Class Millionaire: From $80K in Debt to $3M in Profits through Catalyst Trading, Option Rocket Kyle Dennis, Option Rocket Review, Option Rocket Reviews, Option Rocket Scam, Options Rocket Kyle Dennis, Options Rocket login, Options Rocket Review, Options Rocket Reviews, Options Rocket Scam, Options Rocket User experience, Options Rocket user review, Options Rocket webinar, Options Rocket website, RagingBull Fortune Forecaster, RagingBull Fortune Forecaster Review, RagingBull Fortune Forecaster Reviews, RagingBull Fortune Forecaster Scam, The Heist, The Heist Kyle Dennis, The Heist Review, The Heist Scam
Jason Bond Weekly Windfalls Review | Selling Options
NFLX Earnings: Here’s What the Market Is Saying | Jeff Bishop Weekly Money Multiplier Service

Marc Chaikin Prediction - Top Stocks to Buy in 2024

Marc Chaikin Prediction

Join our list

2023 Wealth Protection Kit

Investment in Gold or Silver

“Get The FREE 2023 Wealth Protection Kit Americans Are Using To Protect Their Retirement Savings” – Sean Hannity

Click Here to Request Your Free Guide

Top 7 Trading Resources

Best Trading Advice

Steady Income Investments

Crypto News

Options Trading Strategies

Top Marijuana Stocks

FREE Trade Alerts

Best Blockchain Stocks to Buy

© 2023 Investment Resources • Built with GeneratePress