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grande DD

BMSN*Valuation(s), FDA, & Orphan Drug Thoughts…

Below is a compilation of my posts of which some of the info has been edited to add more clarity, but most of it is as I had originally posted over the past few weeks.

Bio-Matrix Scientific Group Inc. (BMSN): Significance of BMSN IND & Breast Cancer Treatment
Significance of BMSN IND & Breast Cancer Treatment News…

Significant for understanding, read the post/link below:
Bio-Matrix Scientific Group Inc. (BMSN): cowboydancer, with these important BMSN thoughts…

Quote:
--------------------------------------------------------------------------------
... HemaXellerate I™ is eligible for Orphan Drug designation where from such, there is a 70% chance that the FDA will give an accelerated approval. Even before then, there is an 85% chance that Investigational New Drug (IND) applications gets approved.
--------------------------------------------------------------------------------



Below is some key info to help investors to understand the importance of this breast cancer treatment news (also looks like their drug will be used to treat prostate cancer too. Within this post, you will be able to see how this news ”potentially” positions BMSN to be able to make billions of dollars per year just from this breast cancer piece alone.

Please, don’t just believe me. Read through this post and do the math yourself.

Below are some links to confirm that there is basically around 220,000+ new cases of breast cancer in the US and 1,300,000+ new cases of breast cancer worldwide that are diagnosed. One could also Google this data to research to see that such is correctly and vastly considered:
CDC - Breast Cancer Statistics
GLOBOCAN Cancer Fact Sheets: Breast Cancer
Breast cancer : Cancer Research UK

This is very significant and very powerful with understanding this recent news from BMSN’s wholly owned subsidiary Regen BioPharma, Inc. positioning itself to own the patented intellectual property covering a novel means of treating breast cancer by augmenting the immune system using a "gene silencing" approach.

As per the PR…
Bio-Matrix' Regen BioPharma Executes LOI to Acquire Issued US Patent Covering Cancer Gene-Silencing Technology for Use in Tre...

Quote:
--------------------------------------------------------------------------------

Provenge is a vaccine for prostate cancer that costs $93,000 per treatment cycle(1) and had sales of $240 million in the last three quarters of 2012, despite only increasing survival by 4.1 months(2). Dendreon's Provenge requires extraction of dendritic cells, a "master cell" of the immune system, and manipulation outside of the body. The technology developed by Professor Min involves "training" of the same dendritic cells inside of the body by administration of specific nanoparticles. Proof of concept of these nanoparticles were published by Professor Min in collaboration with University of California San Diego in the prestigious scientific journal Blood (Zheng et al. Blood. 2009 Mar 19;113(12):2646-54). …
--------------------------------------------------------------------------------



For inquiring minds, Dendreon Corp. trades under the ticker of DNDN on the NASDAQ GS at $5.40+ per share:
DNDN: Summary for Dendreon Corporation- Yahoo! Finance

If Dendreon’s cancer vaccine/medicine called Provenge that has already been approved by the FDA costs $93,000 per treatment and is considered the best thing out there now for fighting cancer and can generate Revenues of $240,000,000 for just three quarters, then BMSN’s technique for its own cancer medicine under their "gene silencing" approach that’s considered 100% times better can be sold for at least the same $93,000 per treatment or higher upon FDA approval in my opinion which could generate far more in Revenues.

As I had indicated above, there are basically around 220,000+ new cases of breast cancer in the US and 1,300,000+ new cases of breast cancer worldwide that are diagnosed.

Potential Annual Revenues within the US:
220,000 US New Cases x $93,000 per treatment = $20,460,000,000

Potential Annual Revenues within the World:
1,300,000 Worldwide New Cases x $93,000 per treatment = $120,900,000,000

With keeping things real, please understand that it is not likely that BMSN would treat everyone within the world although the potential to consider such exists. So I would not expect those numbers above although a few billion still would not be out of the question considering that their treatment would apply to a few other types of cancer treatments too.

A more conservative number would be to know that BMSN probably would only be able to treat somewhere in the area of 3,500 patients per year from researching the norm for some other companies on the major market in a fairly perfect world. This means that a more conservative number would be as indicated below…

Potential Annual Revenues from probable amount to receive cancer treatment:
3,500 Probable Amount Treated x $93,000 per treatment = $325,500,000

As you can see, this is in line with what some of the major market stocks/companies are generating from the sale of their treatments. Still, the potential is there to make well above that amount when you start considering treatment for prostate cancer and other cancers. There is roughly an 11% profit Margin for stocks within the Biotech Industry as indicated below:
Industry Browser - Healthcare - Biotechnology Industry - Company List

This makes the above amount of ”potential” Revenues from this breast cancer piece to be about $35,805,000 in Revenues for BMSN as derived below:

$325,000,000 x 11% Net Profit Margin = $35,805,000 in Net Profit/Income

Per the recent 8-K below, the BMSN Outstanding Shares (OS) is 1,035,911,549 shares:
biomatrix8k.htm

Now consider the formulas below to derive a “potential” ”Fundamental Valuation” for BMSN from its breast cancer drug (the HemaXellerate I™ is a different drug and a valuation is explained further below within this post):

Net Profit/Income ÷ OS = Earnings Per Share (EPS)
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share

So…

Net Profit/Income ÷ OS = Earnings Per Share (EPS)
$35,805,000 Net Profit/Income ÷ 1,035,911,549 OS = .0345 Earnings Per Share (EPS)

I will use the P/E Ratio for this breast cancer drug potential that I used in a previous valuation post for BMSN’s HemaXellerate I™ stem cell drug since it is far more conservative than the current P/E Ratio for the Biotech Industry.

EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
.0345 EPS x 57.80 P/E Ratio = $1.99 per share

As stated from this news, which confirms the validity of their approach, this gene silencing therapy was developed through over 1.5 million dollars of grant funding at the University of Western Ontario, Canada. This approach offers the possibility of destroying tumors in a non-toxic manner through leveraging the body's own immune system to recognize the cancer as "foreign" and subsequently eradicating it.
Bio-Matrix' Regen BioPharma Executes LOI to Acquire Issued US Patent Covering Cancer Gene-Silencing Technology for Use in Tre...


BMSN & the Merk & Co. Connection…

As per Professor Min…
Bio-Matrix' Regen BioPharma Executes LOI to Acquire Issued US Patent Covering Cancer Gene-Silencing Technology for Use in Tre...

Quote:
--------------------------------------------------------------------------------
"For more than a decade our laboratory's focus has been to identify how to use gene silencing in the context of immunology. We are enthusiastic to have partnered with Bio-Matrix' Regen BioPharm. We believe this novel approach in treating breast cancer will greatly enhance outcomes for patients," said Professor Min. "While Dendreon's Provenge cancer vaccine has provided an industry precedent for immunotherapy as a practical alternative in oncology, we believe that our approach is capable at competing both at the cost, and efficacy level."
--------------------------------------------------------------------------------



In my opinion, when BMSN added Dr. Wei-Ping Min to their Scientific Advisory Board, it linked BMSN to be in the eyes of Merk & Co. which trades on the NYSE:MRK at $42.00+ per share.

There is absolutely no way Dr. Wei-Ping Min would associate himself with BMSN unless he knew 100% that BMSN had something very worthy of note to be a part of supporting. Because of Dr. Wei-Ping Min’s credentials, if he believes that BMSN is not a scam and is very real, then I will truly trust his due diligence (DD) to do such too.

Dr. Wei-Ping Min is the inventor of siRNA therapeutics which was bought out by Merk & Co for $13.00 per share:

Quote:
--------------------------------------------------------------------------------

Sirna Therapeutics holders OK $1.1 bln acquisition by Merck - MarketWatch
Sirna Therapeutics holders OK $1.1 bln acquisition by Merck

SAN FRANCISCO (MarketWatch) -- Sirna Therapeutics Inc. said Thursday that its shareholders have approved the company's acquisition by Merck & Co. (US:mrk). In late October, Merck agreed to acquire San Francisco-based Sirna for $13 a share in cash, or $1.1 billion. Sirna develops therapeutics using RNA interference, which aims to treat diseases by disrupting the expression of disease-causing genes. The transaction is expected to close as soon as reasonably practicable, the company said.

--------------------------------------------------------------------------------



Below is confirmation of BMSN making such a move to add Dr. Wei-Ping Min to their Scientific Advisory Board:

Quote:
--------------------------------------------------------------------------------

Bio-Matrix' Regen BioPharma Unit Establishes Scientific Advisory Board and Research Relationship With Clinartis in Anticipation of Beginning Clinical Development Stem Cell Studies - Yahoo! Finance
Dr. Wei-Ping Min is Professor at the Lawson Health Research Center in Canada. He is inventor of siRNA therapeutics in the area of immunology and cell therapy to inhibit disease modalities. He is also the founder/cofounder of several biotech companies including MedVax Pharma Corp, and ToleroTech Inc. Dr. Min brings detailed scientific and mechanistic expertise to Regen BioPharma. He earned graduate and medical degrees from Nanchang University Medical School and the PhD degree from Kyushu University.

--------------------------------------------------------------------------------



Here’s a little bit more about Dr. Wei-Ping Min:

RNA interference: a potent tool for gene-specific therapeutics. | ResearchGate


More About Dr. Weiping Min, M.D.
Bio-Matrix Scientific Group Inc. (BMSN): http://regenbiopharma.com/advisory-board.html"Weiping Min, M.D.
SCIENTIFIC ADVISORY BOARD | REGEN BIOPHARMA, INC.



Bio-Matrix Scientific Group Inc. (BMSN): BMSN Investigational New Drug (IND) Application
cowboydancer, with these important BMSN thoughts…

These important BMSN thoughts you have posted are right in line with what I have confirmed from personally speaking with the FDA Office. The info below was taken directly from the FDA website and is what I was personally told by the FDA office…

Guidance for Industry Fast Track Drug Development Programs — Designation, Development, and Application Review
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf

On Page 9


On Page 17…
 
grande DD

BMSN*Valuation(s), FDA, & Orphan Drug Thoughts…

Below is a compilation of my posts of which some of the info has been edited to add more clarity, but most of it is as I had originally posted over the past few weeks.

Bio-Matrix Scientific Group Inc. (BMSN): Significance of BMSN IND & Breast Cancer Treatment
Significance of BMSN IND & Breast Cancer Treatment News…

Significant for understanding, read the post/link below:
Bio-Matrix Scientific Group Inc. (BMSN): cowboydancer, with these important BMSN thoughts…

Quote:
--------------------------------------------------------------------------------
... HemaXellerate I™ is eligible for Orphan Drug designation where from such, there is a 70% chance that the FDA will give an accelerated approval. Even before then, there is an 85% chance that Investigational New Drug (IND) applications gets approved.
--------------------------------------------------------------------------------



Below is some key info to help investors to understand the importance of this breast cancer treatment news (also looks like their drug will be used to treat prostate cancer too. Within this post, you will be able to see how this news ”potentially” positions BMSN to be able to make billions of dollars per year just from this breast cancer piece alone.

Please, don’t just believe me. Read through this post and do the math yourself.

Below are some links to confirm that there is basically around 220,000+ new cases of breast cancer in the US and 1,300,000+ new cases of breast cancer worldwide that are diagnosed. One could also Google this data to research to see that such is correctly and vastly considered:
CDC - Breast Cancer Statistics
GLOBOCAN Cancer Fact Sheets: Breast Cancer
Breast cancer : Cancer Research UK

This is very significant and very powerful with understanding this recent news from BMSN’s wholly owned subsidiary Regen BioPharma, Inc. positioning itself to own the patented intellectual property covering a novel means of treating breast cancer by augmenting the immune system using a "gene silencing" approach.

As per the PR…
Bio-Matrix' Regen BioPharma Executes LOI to Acquire Issued US Patent Covering Cancer Gene-Silencing Technology for Use in Tre...

Quote:
--------------------------------------------------------------------------------

Provenge is a vaccine for prostate cancer that costs $93,000 per treatment cycle(1) and had sales of $240 million in the last three quarters of 2012, despite only increasing survival by 4.1 months(2). Dendreon's Provenge requires extraction of dendritic cells, a "master cell" of the immune system, and manipulation outside of the body. The technology developed by Professor Min involves "training" of the same dendritic cells inside of the body by administration of specific nanoparticles. Proof of concept of these nanoparticles were published by Professor Min in collaboration with University of California San Diego in the prestigious scientific journal Blood (Zheng et al. Blood. 2009 Mar 19;113(12):2646-54). …
--------------------------------------------------------------------------------



For inquiring minds, Dendreon Corp. trades under the ticker of DNDN on the NASDAQ GS at $5.40+ per share:
DNDN: Summary for Dendreon Corporation- Yahoo! Finance

If Dendreon’s cancer vaccine/medicine called Provenge that has already been approved by the FDA costs $93,000 per treatment and is considered the best thing out there now for fighting cancer and can generate Revenues of $240,000,000 for just three quarters, then BMSN’s technique for its own cancer medicine under their "gene silencing" approach that’s considered 100% times better can be sold for at least the same $93,000 per treatment or higher upon FDA approval in my opinion which could generate far more in Revenues.

As I had indicated above, there are basically around 220,000+ new cases of breast cancer in the US and 1,300,000+ new cases of breast cancer worldwide that are diagnosed.

Potential Annual Revenues within the US:
220,000 US New Cases x $93,000 per treatment = $20,460,000,000

Potential Annual Revenues within the World:
1,300,000 Worldwide New Cases x $93,000 per treatment = $120,900,000,000

With keeping things real, please understand that it is not likely that BMSN would treat everyone within the world although the potential to consider such exists. So I would not expect those numbers above although a few billion still would not be out of the question considering that their treatment would apply to a few other types of cancer treatments too.

A more conservative number would be to know that BMSN probably would only be able to treat somewhere in the area of 3,500 patients per year from researching the norm for some other companies on the major market in a fairly perfect world. This means that a more conservative number would be as indicated below…

Potential Annual Revenues from probable amount to receive cancer treatment:
3,500 Probable Amount Treated x $93,000 per treatment = $325,500,000

As you can see, this is in line with what some of the major market stocks/companies are generating from the sale of their treatments. Still, the potential is there to make well above that amount when you start considering treatment for prostate cancer and other cancers. There is roughly an 11% profit Margin for stocks within the Biotech Industry as indicated below:
Industry Browser - Healthcare - Biotechnology Industry - Company List

This makes the above amount of ”potential” Revenues from this breast cancer piece to be about $35,805,000 in Revenues for BMSN as derived below:

$325,000,000 x 11% Net Profit Margin = $35,805,000 in Net Profit/Income

Per the recent 8-K below, the BMSN Outstanding Shares (OS) is 1,035,911,549 shares:
biomatrix8k.htm

Now consider the formulas below to derive a “potential” ”Fundamental Valuation” for BMSN from its breast cancer drug (the HemaXellerate I™ is a different drug and a valuation is explained further below within this post):

Net Profit/Income ÷ OS = Earnings Per Share (EPS)
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share

So…

Net Profit/Income ÷ OS = Earnings Per Share (EPS)
$35,805,000 Net Profit/Income ÷ 1,035,911,549 OS = .0345 Earnings Per Share (EPS)

I will use the P/E Ratio for this breast cancer drug potential that I used in a previous valuation post for BMSN’s HemaXellerate I™ stem cell drug since it is far more conservative than the current P/E Ratio for the Biotech Industry.

EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
.0345 EPS x 57.80 P/E Ratio = $1.99 per share

As stated from this news, which confirms the validity of their approach, this gene silencing therapy was developed through over 1.5 million dollars of grant funding at the University of Western Ontario, Canada. This approach offers the possibility of destroying tumors in a non-toxic manner through leveraging the body's own immune system to recognize the cancer as "foreign" and subsequently eradicating it.
Bio-Matrix' Regen BioPharma Executes LOI to Acquire Issued US Patent Covering Cancer Gene-Silencing Technology for Use in Tre...


BMSN & the Merk & Co. Connection…

As per Professor Min…
Bio-Matrix' Regen BioPharma Executes LOI to Acquire Issued US Patent Covering Cancer Gene-Silencing Technology for Use in Tre...

Quote:
--------------------------------------------------------------------------------
"For more than a decade our laboratory's focus has been to identify how to use gene silencing in the context of immunology. We are enthusiastic to have partnered with Bio-Matrix' Regen BioPharm. We believe this novel approach in treating breast cancer will greatly enhance outcomes for patients," said Professor Min. "While Dendreon's Provenge cancer vaccine has provided an industry precedent for immunotherapy as a practical alternative in oncology, we believe that our approach is capable at competing both at the cost, and efficacy level."
--------------------------------------------------------------------------------



In my opinion, when BMSN added Dr. Wei-Ping Min to their Scientific Advisory Board, it linked BMSN to be in the eyes of Merk & Co. which trades on the NYSE:MRK at $42.00+ per share.

There is absolutely no way Dr. Wei-Ping Min would associate himself with BMSN unless he knew 100% that BMSN had something very worthy of note to be a part of supporting. Because of Dr. Wei-Ping Min’s credentials, if he believes that BMSN is not a scam and is very real, then I will truly trust his due diligence (DD) to do such too.

Dr. Wei-Ping Min is the inventor of siRNA therapeutics which was bought out by Merk & Co for $13.00 per share:

Quote:
--------------------------------------------------------------------------------

Sirna Therapeutics holders OK $1.1 bln acquisition by Merck - MarketWatch
Sirna Therapeutics holders OK $1.1 bln acquisition by Merck

SAN FRANCISCO (MarketWatch) -- Sirna Therapeutics Inc. said Thursday that its shareholders have approved the company's acquisition by Merck & Co. (US:mrk). In late October, Merck agreed to acquire San Francisco-based Sirna for $13 a share in cash, or $1.1 billion. Sirna develops therapeutics using RNA interference, which aims to treat diseases by disrupting the expression of disease-causing genes. The transaction is expected to close as soon as reasonably practicable, the company said.

--------------------------------------------------------------------------------



Below is confirmation of BMSN making such a move to add Dr. Wei-Ping Min to their Scientific Advisory Board:

Quote:
--------------------------------------------------------------------------------

Bio-Matrix' Regen BioPharma Unit Establishes Scientific Advisory Board and Research Relationship With Clinartis in Anticipation of Beginning Clinical Development Stem Cell Studies - Yahoo! Finance
Dr. Wei-Ping Min is Professor at the Lawson Health Research Center in Canada. He is inventor of siRNA therapeutics in the area of immunology and cell therapy to inhibit disease modalities. He is also the founder/cofounder of several biotech companies including MedVax Pharma Corp, and ToleroTech Inc. Dr. Min brings detailed scientific and mechanistic expertise to Regen BioPharma. He earned graduate and medical degrees from Nanchang University Medical School and the PhD degree from Kyushu University.

--------------------------------------------------------------------------------



Here’s a little bit more about Dr. Wei-Ping Min:

RNA interference: a potent tool for gene-specific therapeutics. | ResearchGate


More About Dr. Weiping Min, M.D.
Bio-Matrix Scientific Group Inc. (BMSN): http://regenbiopharma.com/advisory-board.html"Weiping Min, M.D.
SCIENTIFIC ADVISORY BOARD | REGEN BIOPHARMA, INC.



Bio-Matrix Scientific Group Inc. (BMSN): BMSN Investigational New Drug (IND) Application
cowboydancer, with these important BMSN thoughts…

These important BMSN thoughts you have posted are right in line with what I have confirmed from personally speaking with the FDA Office. The info below was taken directly from the FDA website and is what I was personally told by the FDA office…

Guidance for Industry Fast Track Drug Development Programs — Designation, Development, and Application Review
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf

On Page 9


On Page 17…

Purtroppo essendo io un ignorante totale non ci ho capito molto:wall::wall::wall::wall:
Ma....credo di aver capito che circolano 1,035,911,549 azioni e non e' irrealizzabile (almeno sulla carta) il target di 1,99 $ ad azione.
Giusto???:confused::confused::confused:
 
con tutta la notizia sembra ancora stabile su quel punto..... bisogna attendere l' FDA che si pronuncia sull'esito.....
 
ormai si contano i giorni alla scadenza
 
attendiamo fiduciosi, certo che i rumors fanno pensare ad un ottima notizia dell 'FDA , ma bisogna star sereni ed incrociare le dita
 
basta vedere il volume..
anticipa la news

si è acceso adesso
 
se tiene cosi..perchè siamo alla news
prima del fine settimana
 
+ 14 % chissà cosa accade
 
axellll che pronostici hai???
 
Indietro