August 1 Biotech Update

The sector recovered a little yesterday from last week’s sell-off but ideally we would need to see the sector break into new highs. It seems highly likely that the sector.

BIIB Option Trade – A Response to Dave

Dave made a good case to play the BIIB data next week. He is leaning bullish, which could make price explode past $400. his downside expectation is between $300 and.

FDA GT Draft Guidance is Bullish for Sarepta's DMD Pivotal Trial

Yesterday July 11, 2018 the FDA FDA issues 6 new draft guidance documents for gene therapy, clinical development and manufacturing guidance. Human Gene Therapy for Rare Diseases – FDA Draft Guidance for.

SRPT – Building a Precision Genetic Medicine Powerhouse

Sarepta Therapeutics (SRPT) is attempting to build the most meaningful precision genetic medicine company in the world, and has laid out its strategy to investors of exactly how it plans.

PSTI – Placenta Stem-Cells Brings Hope to PAD-Peripheral Artery Disease Patients

Intermittent Claudication or as called IC is a peripheral artery disease (PAD) caused by fatty deposits that accumulate in the arteries of the leg and reduce blood flow to exercising muscle.

PSTI – Ahead of IC Phase-2 Top-Line Results

PLURISTEM (PSTI) a cell therapy company, developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions, company I’m following for years.  Pluristem trading under.

Dave Trading – May 2018

*** David Sobek is a disciplined value investor.  Using models, research, and fundamental data, David devises a value for biotech stocks, buys when significantly undervalued, and sells when significantly overvalued.***.

What Do You Need To Know Ahead of Next Week – SRPT CHMP Oral-Explanation

The CHMP meeting will take place next week April 23-26, we have no idea what day exactly is SRPT meeting, (Update 04/23:  today the CHMP published this week agenda and.

SRPT – Preparing For The CHMP Oral-Explanation

It was an intense week for SRPT’s investors, where the share price bounced from $74.36 (close Friday 03/09) to reach the high of $84.37 this week after the press release.

SRPT Was and Still The DMD Gene Therapy Leader

Today after the market close, Solid Biosciences (SLDB) announced it has received notification from the U.S. Food and Drug Administration (FDA) that IGNITE DMD, its Phase I/II clinical trial for.

Celldex: Quick Take

Celldex has struggled for a couple years now since its brain cancer drug Rintega failed in 2016. In Q2 this year, results from a pivotal study of the gpNMB antibody.

Sarepta Official Statement Regarding The UK Study Halt

This morning, EP Vantage reported a temporary UK study halt in dosing after “one serious adverse event that could possibly be related to the investigational drug product” but the halt was for.

Dr. James Wilson Paper About Safety Concerns, Is Not Sarepta’s Concern!

Today morning, most of the gene-therapy stocks including SLDB, AVXS, ONCE, RGNX, BOLD, ABEO and even SRPT Stumbled following Dr. James Wilson paper published online “Severe toxicity in nonhuman primates.

Achaogen: Is It A Buy?

South San Francisco based Achaogen is on the verge of gaining FDA approval for its bacteria fighting drug Plazomicin. The decision date has been set for June 25 with an.

The Kodak Hail Mary

Kodak is just the latest in a series of companies that rescued a failing stock price by announcing a crypto-currency scheme. While there is a Kodak crypto-currency that will be.

What is the Difference (Crypto-Currencies)

What’s the Difference? There are hundreds and soon to be thousands of crypto-currencies. It is impossible to know them all but I want to highlight some of the important aspects.

What Drives the Bitcoin Market?

What is Bitcoin? To answer that question we need a good analogy as to what bitcoin actually is or what it is supposed to do. Bitcoin as a Digital Currency.

The Bitcoin Bubble

Bitcoin is a bubble. Bitcoin is overvalued. There is a lot of hysteria about bitcoin but that is from both those drinking the koolaid as well as those screaming bubble.

Dave-Trading – December 2017

*** David Sobek is a disciplined value investor.  Using models, research, and fundamental data, David devises a value for biotech stocks, buys when significantly undervalued, and sells when significantly overvalued.***.

SRPT – Preparing For Blast Of Catalysts

Already a year has passed since Sarepta’s first drug Exondys51 was granted FDA approval on 09/19/2016. The landmark decision by Janet Woodcock, despite the review team’s opposition, gave hope to.

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