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Friday, February 05, 2016 1:07:17 AM
$PMCB What Are Clinical Stage Biotech Stocks?
Many small cap biotech stocks like Pharmacyte Biotech Inc (OTCQB: PMCB) call themselves “clinical stage biotech stock.” Here is what you need to know when a biotech stock says they are in the clinical stage.
If you are an investor new to biotech investing, you might be wondering what is meant when a small cap biotech stock like Pharmacyte Biotech Inc (OTCQB: PMCB) calls themselves a “clinical stage biotech stock” or company. After all, many small cap biotech stocks like Pharmacyte Biotech are still in the clinical stage; but such stocks tend to not be the best of investments for risk adverse or novice investors.
What Are Clinical Stage Biotech Stocks?
When a small cap biotech stock calls themselves a clinical stage biotech stock, it usually means they do not yet have any drugs or treatments approved by the FDA or other appropriate regulatory authorities in other countries. For that reason, you should be aware of and have an understanding of the phases of drug development:
An Investigational New Drug Application (IND) is made to the FDA showing results of any study done in the laboratory.
Clinical Phase I involves studies performed on a small group of healthy volunteers to see how a new drug is metabolized in the human body as well as to determine the dose and dosage interval that will have a positive effect on the disease or problem without unwanted side-effects.
Clinical Phase II involves treating a larger group of patients to demonstrate a new drug's efficacy and to confirm its safety with comparisons often being made with another group receiving inactive placebo treatment.
Clinical Phase III’s main goal is to prove that any promising effects seen in Phase II can also be obtained in larger patient groups with great importance being attached to safety issues, documentation and production preparations.
Submission of a New Drug Application to the FDA will usually occur at this point and it should be kept in mind there is still no guarantee that the FDA will approve something – even if Phase I to Phase III trials or studies resulted in positive data or results. Sometime the FDA will ask for further studies or clarifications.
Keep in mind that most drug clinical trials will fail to achieve their goals – meaning you should look for clinical stage biotech stocks that have diversified drug pipelines or are building drug platforms that have the potential to treat multiple conditions.
With that said and if you are a risk adverse investor, you would be better off buying established biotech stocks that are beyond the clinical stage with approved drugs, are profitable and have developed drug pipelines. The downside about such biotech stocks is that they are already on Wall Street's radar and the trading screen of every other biotech stock trader/investor out there – meaning you have probably missed the big homerun, share pop or lottery ticket winner.
Clinical Stage Biotech Stock Example: PharmaCyte Biotech
Small cap PharmaCyte Biotech is a good example of a clinical stage biotechnology company that’s probably still off the radar screen of Wall Street and most biotech investors as its still trading on the OTC. PharmaCyte Biotech is focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box.
More specifically, the technology encloses living cells in protective “cocoons” or “capsules” about the size of the head of a pin. The live cells inside the Cell-in-a-Box® capsules are then nourished and thrive while the capsules are in the body and are protected from attack by the body’s immune system because they cannot escape from the capsules and immune system cells cannot enter the capsules and destroy them.
PharmaCyte Biotech’s Cell-in-a-Box encapsulation differs from those produced by others as competitors use substances such as alginate (a seaweed derivative) or chitosan whereas PMCB’s capsules are made principally of cellulose, a bio-inert material in the human body.
For the second half of the year, PharmaCyte Biotech has been busy making various announcements worth noting by investors:
$PMCB recent news/filings
## source: finance.yahoo.com
Mon, 25 Jan 2016 17:47:09 GMT ~ PharmaCyte Executives Meet With Translational Drug Development to Advance Pancreatic Cancer Clinical Trial
[at noodls] - SILVER SPRING, Md., Jan. 25, 2016 (GLOBE NEWSWIRE) - PharmaCyte Biotech, Inc. (PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its ...
read full: http://www.publicnow.com/view/28F42A22A64DD4473B7669A8E686AE2F2A16F544
*********************************************************
Mon, 25 Jan 2016 14:25:00 GMT ~ PharmaCyte Executives Meet With Translational Drug Development to Advance Pancreatic Cancer Clinical Trial
[GlobeNewswire] - SILVER SPRING, Md., Jan. 25, 2016-- PharmaCyte Biotech, Inc., a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation ...
read full: http://finance.yahoo.com/news/pharmacyte-executives-meet-translational-drug-142500942.html
*********************************************************
Sat, 23 Jan 2016 18:04:15 GMT ~ PHARMACYTE BIOTECH, INC. Financials
read full: http://finance.yahoo.com/q/is?s=pmcb
*********************************************************
Thu, 21 Jan 2016 14:12:00 GMT ~ The Road Ahead -- Featured Research on SpectraScience, Pharmacyte Biotech, Silvercorp Metals and Aytu BioScience
[Accesswire] - NEW YORK, NY / ACCESSWIRE / January 21, 2016 / Moments ago, Trader's Choice released new research updates concerning several important developing situations including the following equities: SpectraScience ...
read full: http://finance.yahoo.com/news/road-ahead-featured-research-spectrascience-141200909.html
*********************************************************
Tue, 19 Jan 2016 22:34:55 GMT ~ PHARMACYTE BIOTECH, INC. Files SEC form 10-K/A, Annual Report
read full: http://biz.yahoo.com/e/160119/pmcb10-k_a.html
*********************************************************
PharmaCyte Biotech Adds Cancer Drug All-Star to Its Scientific Advisory Board Marketwired (Tue, Jul 21)
PharmaCyte Biotech would be down 62.8% since the start of the year – not necessarily a bad sign as the stock is a clinical stage biotech. Nevertheless, shares are still up 346.7% over the past five years.
Many small cap biotech stocks like Pharmacyte Biotech Inc (OTCQB: PMCB) call themselves “clinical stage biotech stock.” Here is what you need to know when a biotech stock says they are in the clinical stage.
If you are an investor new to biotech investing, you might be wondering what is meant when a small cap biotech stock like Pharmacyte Biotech Inc (OTCQB: PMCB) calls themselves a “clinical stage biotech stock” or company. After all, many small cap biotech stocks like Pharmacyte Biotech are still in the clinical stage; but such stocks tend to not be the best of investments for risk adverse or novice investors.
What Are Clinical Stage Biotech Stocks?
When a small cap biotech stock calls themselves a clinical stage biotech stock, it usually means they do not yet have any drugs or treatments approved by the FDA or other appropriate regulatory authorities in other countries. For that reason, you should be aware of and have an understanding of the phases of drug development:
An Investigational New Drug Application (IND) is made to the FDA showing results of any study done in the laboratory.
Clinical Phase I involves studies performed on a small group of healthy volunteers to see how a new drug is metabolized in the human body as well as to determine the dose and dosage interval that will have a positive effect on the disease or problem without unwanted side-effects.
Clinical Phase II involves treating a larger group of patients to demonstrate a new drug's efficacy and to confirm its safety with comparisons often being made with another group receiving inactive placebo treatment.
Clinical Phase III’s main goal is to prove that any promising effects seen in Phase II can also be obtained in larger patient groups with great importance being attached to safety issues, documentation and production preparations.
Submission of a New Drug Application to the FDA will usually occur at this point and it should be kept in mind there is still no guarantee that the FDA will approve something – even if Phase I to Phase III trials or studies resulted in positive data or results. Sometime the FDA will ask for further studies or clarifications.
Keep in mind that most drug clinical trials will fail to achieve their goals – meaning you should look for clinical stage biotech stocks that have diversified drug pipelines or are building drug platforms that have the potential to treat multiple conditions.
With that said and if you are a risk adverse investor, you would be better off buying established biotech stocks that are beyond the clinical stage with approved drugs, are profitable and have developed drug pipelines. The downside about such biotech stocks is that they are already on Wall Street's radar and the trading screen of every other biotech stock trader/investor out there – meaning you have probably missed the big homerun, share pop or lottery ticket winner.
Clinical Stage Biotech Stock Example: PharmaCyte Biotech
Small cap PharmaCyte Biotech is a good example of a clinical stage biotechnology company that’s probably still off the radar screen of Wall Street and most biotech investors as its still trading on the OTC. PharmaCyte Biotech is focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box.
More specifically, the technology encloses living cells in protective “cocoons” or “capsules” about the size of the head of a pin. The live cells inside the Cell-in-a-Box® capsules are then nourished and thrive while the capsules are in the body and are protected from attack by the body’s immune system because they cannot escape from the capsules and immune system cells cannot enter the capsules and destroy them.
PharmaCyte Biotech’s Cell-in-a-Box encapsulation differs from those produced by others as competitors use substances such as alginate (a seaweed derivative) or chitosan whereas PMCB’s capsules are made principally of cellulose, a bio-inert material in the human body.
For the second half of the year, PharmaCyte Biotech has been busy making various announcements worth noting by investors:
$PMCB recent news/filings
## source: finance.yahoo.com
Mon, 25 Jan 2016 17:47:09 GMT ~ PharmaCyte Executives Meet With Translational Drug Development to Advance Pancreatic Cancer Clinical Trial
[at noodls] - SILVER SPRING, Md., Jan. 25, 2016 (GLOBE NEWSWIRE) - PharmaCyte Biotech, Inc. (PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its ...
read full: http://www.publicnow.com/view/28F42A22A64DD4473B7669A8E686AE2F2A16F544
*********************************************************
Mon, 25 Jan 2016 14:25:00 GMT ~ PharmaCyte Executives Meet With Translational Drug Development to Advance Pancreatic Cancer Clinical Trial
[GlobeNewswire] - SILVER SPRING, Md., Jan. 25, 2016-- PharmaCyte Biotech, Inc., a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation ...
read full: http://finance.yahoo.com/news/pharmacyte-executives-meet-translational-drug-142500942.html
*********************************************************
Sat, 23 Jan 2016 18:04:15 GMT ~ PHARMACYTE BIOTECH, INC. Financials
read full: http://finance.yahoo.com/q/is?s=pmcb
*********************************************************
Thu, 21 Jan 2016 14:12:00 GMT ~ The Road Ahead -- Featured Research on SpectraScience, Pharmacyte Biotech, Silvercorp Metals and Aytu BioScience
[Accesswire] - NEW YORK, NY / ACCESSWIRE / January 21, 2016 / Moments ago, Trader's Choice released new research updates concerning several important developing situations including the following equities: SpectraScience ...
read full: http://finance.yahoo.com/news/road-ahead-featured-research-spectrascience-141200909.html
*********************************************************
Tue, 19 Jan 2016 22:34:55 GMT ~ PHARMACYTE BIOTECH, INC. Files SEC form 10-K/A, Annual Report
read full: http://biz.yahoo.com/e/160119/pmcb10-k_a.html
*********************************************************
PharmaCyte Biotech Adds Cancer Drug All-Star to Its Scientific Advisory Board Marketwired (Tue, Jul 21)
PharmaCyte Biotech would be down 62.8% since the start of the year – not necessarily a bad sign as the stock is a clinical stage biotech. Nevertheless, shares are still up 346.7% over the past five years.
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