Apple Inc. (AAPL) Message Board

oh well

markets correction. May walk away on the way.

warning

before 2 late

inappropriate time

and cashing in

fools rally

people will take profits

thing of the past

I feel that Galena biopharma is taking what it has learned from previous cancer vaccine failures, and using Neuvax to generate good results. Gale currently trades at around $2.81 per share, but if phase 3 goes well the stock could see a huge boost into the double digits. Neuvax could be a game changer in the field of vaccines fighting cancer. Its first target indication is targeting breast cancer, which has a market opportunity seen to be in the billions.

The company doesn't just stop on breast cancer alone. It is also in early stage testing of Prostate cancer like Dendreon. The downside is that Gale's prostate cancer vaccine is only in phase 1, and it has many years before it will even get to market. Another trial they are working on is on Endometrial, and Ovarian cancer. If
you have a spot in your portfolio for a speculative biotech stock Gale would be a wise choice for those investors who are seeking long term profit.

One under-$10 stock that’s trending very close to trigger a near-term breakout trade is Antares Pharma (ATRS), which is a specialty pharmaceutical company developing and commercializing self-administered parenteral pharmaceutical products and technologies and topical gel-based products. This stock has been moving higher in 2013, with shares up by 12.4%.

If you take a look at the chart for Antares Pharma, you’ll notice that this stock is bouncing sharply to the upside today right off its 50-day moving average of $3.53 a share. This move has started to push shares of ATRS above a key downtrend line that has been acting as resistance for the stock since February. Shares of ATRS are also starting to break out above some near-term overhead resistance at $3.63 to $3.71 a share. That move is quickly pushing the stock within range of triggering another major breakout trade.

I personally don't think management will consider a buyout until Otrexup has been on the market for 1.5 - 2 years. They've put in too much (dilution, staffing, research, etc) to not at least give themselves a shot. It's probably a point of pride for management as well to say they transformed a small licensing based biotech to a full fledged proprietary product company.

But wouldn't a TEVA buyout make more sense? From a business standpoint, TEVA and ATRS probably have a better working relationship than PFE/ATRS but it's splitting hairs. The only thing holding TEVA back is their cash balance. PFE's cash balance dwarfs TEVA's and TEVA's 3B in cash also includes marketable securities (I'm guessing it's IFRS reporting and not GAAP so no distinction is made or necessary).

Scott Matusow is pretty smart and I'll give him credit for predicting the OMPI buyout based on the VOCE letters. The more I think about it, the more it makes sense that horwath is there all along to "spy" on the working relationship between ATRS/TEVA which again, is what SM is saying. But once again, like with OMPI, I think Scott's prediction is 1 year early...again. Bullet to my head? PFE probably takes us out in early-mid 2015 so they can launch QST/QSM and whatever is in the pipeline themselves. Taking us out in 2015 will probably cost them another $1B in cash but they'll still be in a fine cash position to do so. PPS in early 2015 will probably be around $15 on ~2B market cap considering management is lowballing otrexup revenues on
purpose right now. I wouldn't mind a 50%+ premium for a $3B+ buyout. And TEVA won't be able to do anything about it...because they don't have the cash..

A new piece of legislation proposed in the House of Representatives would amend the Federal Food, Drug and Cosmetic Act (FDCA) to allow for the US Food and Drug Administration (FDA) to issue tentative approvals for products given fast track designation.

The bill, H.R. 6288 – The Patient Choice Act of 2012, is sponsored by Rep. Brian Bilbray (R-CA) and currently is co-sponsored by Reps. Dan Boren (R-OK), Morgan Griffith (R-VA), Duncan Hunter (R-CA) and Jean Schmidt (R-OH).

“It is inexcusable that patients have to travel overseas to receive the treatment they need,” stated Bilbray in a statement. “While we continue to streamline the approval process at home, we should recognize the advances made in patient care in other countries that have rigorous approval standards similar to our FDA.”

Bilbray said in a separate statement emailed to congressmen that he had seen, "A surge in companies leaving the US and heading overseas to address this issue," and that long review times and regulatory uncertainty were key drivers in this commercial exodus.
Provisional Approvals under the Act

Under the act, the FDA Commissioner would be required within 90 days—if asked by the product's sponsor—to grant "provisional approval" to drug products designated as a "fast track" product under the law so long as it has been determined to be "adequately safe."

The Act defines a "safe" product as one with a risk of death less than that presented by the disease and its secondary effects. Alternatively, a product is "safe" if it is less risky than a product approved for the same condition. Similarly, if a drug has been marketed in an approved foreign country for more than four years, that data may also be used to support the safety of a drug.

The provisional approval would allow the product to enter interstate commerce—currently only allowed for fully approved products or ones undergoing clinical testing under an approved investigational new drug application.

The bill notes the treatment of the drug is effectively the same as it would be under the sections 505 and 351 of the Public Health Service Act, both of which set the requirements for new drug and biologic products.
Informed Consent and Removal from the Market

Unlike normal drug products given full approval by the agency, marketers of provisionally approved products would be required to obtain written, informed consent from all patients receiving the drug and would also need to continue to obtain safety and efficacy data for the drugs. The bill notes the requirements for this consent would be similar to those in place under Title 21, Part 50 of the Code of Federal Regulations.

The products would also be subject to a five-year period of conditional approval, after which it would be required to pull the product off the market unless FDA determines the sponsor is, "Diligently engaging in actions for the purpose of seeking approval," or requires additional time to obtain approval. The latter could be particularly important for companies given additional requests for long-term Phase III clinical trial requests, some of which can be difficult to find the necessary number of patients to achieve statistical significance.

An additional caveat may be granted by FDA if the product is necessary for the protection of—or if its removal would harm—public health. Any drug found on the market after the time of removal would be classified as misbranded and subject to appropriate action by both FDA and the US Department of Justice.
Continued Momentum

The bill notes, "A sponsor of a drug that receives a provisional approval … shall continue to diligently conduct appropriate studies, after such provisional approval is granted."

All marketing materials to be used by the company will be required to be submitted to FDA 30 days in advance of their use, though prior approval will not be required from FDA for the materials.

Depending on their risk profile, some drugs will also be required to implement a Risk Evaluation and Mitigation Strategies (REMS) plan, which can include black box warnings, patient education plans, restricted prescribing authority, physician education programs and other factors.

The drug's approval would not have any effect on marketing exclusivity provisions contained within federal law, with any additional time on the market being construed as being, "An addition to the applicable period of marketing exclusivity for such drug."

Galena Biopharma (NASDAQ: GALE)

Galena is a biotechnology company involved in the development of oncology treatments. The current valuations of Galena are tied to its leading product candidate, NeuVax. NeuVax is currently in Phase III clinical trials for the prevention of breast cancer recurrence. The company’s Folate Binding Protein-E39 is in Phase 1/2 trials for preventing the recurrence of endometrial adenocarconimas and ovarian cancers.

Galena is currently operating in a healthcare sector, which is facing some serious candidate shortage. This has increased the demand for small biopharmaceutical companies with promising drug candidates. In the last six months, the interest of institutional investors has significantly increased in Galena due to its acquisition prospects and cheap valuations.

Institutions have increased their holdings in Galena by 18% and have added almost 1.5 million shares. The sell-side also has a pretty favorable view of the company and is currently giving a unanimous "buy" rating for the stock. The mean target price is currently $4.90, which is an approximately 100% upside to current price levels.

Conclusion

Investors should avoid Aveo and InterMune for the time being because these companies are witnessing some heaving dumping by institutions, which will continue to beat down the price. Galena remains a top pick in the biotechnology industry due to its cheap valuations and high probability of an acquisition by major players like TEVA and AstraZeneca.