Also, SA prolific authors make money by the read (in addition to undisclosed commission fees).
I recall one who was using esoterism in his analysis.
With a punchy tittle to attract attention and controversial arguments to generate enough discussion around your article, you can make a risk-free quick buck.

Some authors, though, are genuine investors, with all their strengths and weaknesses showing in their analysis, and can be enlightening and insightful to read.
Too bad, they are hidden in the BS smoke.

See post 6633 from insideoutsideupside dated Jun 13 to start refuting this story from AF.

Got a feel for a managed transition:
Wotton leaving due to the languishing down SP since Otrexup approval/ launch,
Hobbs being an experienced and knowledgeable insider with immediate availability.

I am amazed how long Generex has managed to muddle thru with Oral-Lyn...
I recall smiling about their great PRs when it got approved in Equador in 2005, was launched, then withdrawn in India in 2007, and was initiating Ph 3 in US/EU the late 2000s as their Ph 2 data was not impressive...
Then, they started making changes to its formulation.
Then, oh surprise, they started pushing forward their antigen platform for cancer.
And most recently, if I understand this year's presentation at the Annual Meeting, they are talking of a new new formulation...

Thanks for the gift of a new smile today

You focus on current sales... and invest in biotech ?

BTW, in your reference, the "2020 forecast is revised down to $1.5 billion from $2.9 billion"...
Regarding the value of these forecast: Byetta has been approved in 2005 and Bydureon in 2012, with first competitor Victoza in 2010 (all years for US).
At the time of the 2012 acquisition, Byetta sales were going downward in the face of Victoza tremendous growth. Furthermore, Bydureon's own data against Victoza was of failure to show non inferiority.
I wonder how sales could triple with inferior products in the face of competition in the same class.

Also, where did you find this $1 billion for Afrezza ?
I have seen other numbers such as:
MannKind Corporation (MNKD)’s Afrezza Sales To Reach $3.65B By 2025

Regarding Amylin expectation, recall how Byetta launch had been blotched, and how that killed its momentum.
As Novo Nordisk showed with Victoza, the market potential was there: $2.1 billion WW in 2013 (+28% CER) after 3.5 years...

I believe Afrezza product profile, discussed by many other posters, is very promising, as shown by the 27-1 FDAAC vote (14-0 type 2, 13-1 type 1).
As the development of the GLP-1 agonists, DPP-4 inhibitors, and most recently SGLT-2 inhibitors classes have shown, the needs of diabetics are far from being well served, and there is room for Afrezza to open a new segment.

Let me throw-in a comparable: Bristol Myers's acquisition of Amylin for $7 billion in June 2012.

Bristol-Myers Squibb and AstraZeneca Expand Diabetes Alliance Through Bristol-Myers Squibb’s Acquisition of Amylin Pharmaceuticals

That is barely 75% over current market cap, and was for a diabetes company which key product (Byetta/ Bydureon) was clocking $520 M in sales and was losing ground fast to competition ($518, 560, 669 M respectively in 2011, 2010 (1st competitor approved), and 2009.

We are talking of greater sales potential here, thus of even higher valuation for Mannkind...

Keep cool, Fools are made of the same agenda and/or clueless wood as SA's...

Still, regarding your point, it is just a case poorly written article:
LS has another sNDA "to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities" which PDUFA is in Oct 2014.

Navidea Announces Acceptance for Review of an Additional sNDA to Further Expand Lymphoseek® Labeling

Developing an unique and differentiated label as key strategy.
Guiding biopsy is much stronger than just identifying lymph nodes in general.
Additionally (sorry Adam , this creates a new standard of care (SOC) in HN compared to the current one of cutting everything away first, wondering if ever it was useful second.

Sulfur Colloid prescribing information Aug 2012 (latest) indicated:
In adults, to assist in the:
• localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter.
• evaluation of peritoneo-venous (LeVeen) shunt patency.
In adults and pediatric patients, for imaging:
• areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow.
• studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.

Lymphoseek prescribing information Jun 2014 indicated using a hand-held gamma counter for:
• Lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.
• Guiding sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma (SCC) of the oral cavity.

And PPS up 20% ($1.90) since then. (May 28 $1.56 close)
I like the smell of napalm in the morning...

SA negatives ?

4 insiders have sold... with panicky tremors in the voice

Is a giant leap possible... with a somewhat negative feel

10b5-1 autopilot ?

None of the higher-ups are selling.

Before you pop open the champagne, you might have to wait over 7 months... many many weeks indeed

NASDAQ-listed companies not qualifying for continued listing based on market value of listed securities ("MVLS") are notified of a deficiency after 30 consecutive trading days of non-compliance with the applicable standard and are afforded a 180 calendar day compliance period to regain compliance.

So happy I am long gone...
I was curious to see if it would muddle thru. Now I can stop wondering GLTA

10 k filed Mar 31:

(pp 2) "The diltiazem 2% treatment arm demonstrated no significant improvement compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation.
Based on this data, and inasmuch as a primary purpose of our second Phase III trial was to complete the safety data package for an NDA with the FDA, we have requested a pre-NDA FDA meeting to determine the next steps in the program. Depending on the results of that meeting, we expect to be able to file the NDA in the third quarter of 2014."

(pp 54 ) Dr. Ellison serves as our CEO and David J. Barrett serves as our CFO, each pursuant to an employment agreement entered into on January 15, 2014, and effective as of December 22, 2013. ../.. Each new employment agreement has a term of two years and will be automatically extended for additional one-year periods unless we notify the officer at least 180 days prior to the then current expiration date that we intend to not extend the employment agreement. The employment agreements provide for a base salary of $475,000 per year for Dr. Ellison and $300,000 for Mr. Barrett, and an annual discretionary bonus of up to 50% of the officer’s base salary based on financial, clinical development and business milestones established by the Board of Directors. "


10 q filed on May 15:

(pp 17) "Based on our cash position at March 31, 2014, and our analysis of our future development costs, we believe that our existing cash and cash equivalents will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through the FDA approval of VEN 307 and into the second quarter of 2016."


Assembly merger 8 k filed on May 19:

(pp 1) "Once the merger is complete, the company will focus on the development of Assembly’s novel, first-in-class small molecules to treat, and potentially cure, hepatitis B virus (HBV) infection."

(pp 2) "The shares will represent approximately 49% of Ventrus’ outstanding shares of common stock immediately after the Assembly merger, on a fully diluted basis."

(pp 2) "The proposed board and management team would consist of the following Ventrus and Assembly directors and officers, as well as one other director nominee:
- CEO and Chairman – Dr. Russell Ellison currently holds this title at Ventrus.
- President, COO and Director- Derek Small is a co-founder of Assembly and serves as Chairman and CEO.
- CFO – David Barrett currently holds this title at Ventrus.
- VP of R and D and Chief Medical Officer - Uri Lopatin, MD, is a co-founder of Assembly and served in the same position there.
- Chief Scientific Officer – Lee D. Arnold, PhD, has over 25 years of experience at Syntex, Pfizer, BASF/Abbott Bioresearch and OSI Pharmaceuticals. He played an integral role in the discovery of multiple innovative drug candidates that have advanced into development and is an inventor in over sixty patent filings including Tarceva® (erlotinib)"

(pp 17) "Assembly Pharmaceuticals, Inc. was incorporated in Delaware on September 18, 2012"

(pp 19) "As of March 31, 2014, the Company has raised $1,590,000 including $100,000 during 2014"

Not so simple...

Form 4 for Mar 10 sale of 120 CS:

Note 1. Sales were effected to generate funds required to cover tax obligations arising from expiring options or the vesting of shares of restricted stock.
The transaction is matchable under Section 16(b) of the Securities Exchange Act with Dr. Pykett's purchase of 10,900 shares of common stock at $1.35 per share on November 8, 2013. As a result, Dr. Pykett will pay the company $6,649, representing the full amount of the profit realized in connection with the short-swing transaction.


Form 4 for May 09 purchase of 10 CS:

Note 1. The transaction is matchable under Section 16(b) of the Securities Exchange Act with Dr. Pykett's sale of 120,000 shares of common stock at $1.96 per share on March 10, 2014. As a result, Dr. Pykett will pay the company $6,200, representing the full amount of the profit realized in connection with the short-swing transaction.

Jun 11, 2013....

Seems Medac uses BD's Physioject autoinjector platform:
Ypsomed 2012-2013 (May 28, 2013)
slide 25 - "BD has launched new Physioject with Medac for methotrexate."

Physioject appears relatively recent, with an official launch in late 2011, although it has been used in Merck Serono's Rebif RebiDose for multiple sclerosis which was approved in Europe and Australia in October 2010:
BD press release

Interestingly, the first studies in RA were sponsored by BD
human factors study
Results of a human factors experiment of the usability and patient acceptance of a new autoinjector in patients with rheumatoid arthritis
Patient Prefer Adherence. 2014; 8: 199–209.
"Disclosure - The study was funded and sponsored by Becton Dickinson – BD Medical Pharmaceutical Systems"


(added) Regarding the comment of different devices for EU and US, Medac uses the word "autopen" in its Jan 27, 2014 press release, which is the name of autoinjectors from Owen Munford...

From what I can see, Medac's current product in Europe is a plain prefilled syringe...
www.metoject.com

It is what makes the most sense.

Companies don't give the nitty-gritty of their legal actions as most shareholders don't understand what the content mean.

I note Antares is doing exactly what they say they would be doing (Mar 13, 2014 conf call on 2013 results):
"Before moving on, I would like to make a brief statement about recent events regarding litigation that has recently been initiated by Antares, and which has subsequently been initiated against Antares.
As a policy, Antares doesn’t discuss any ongoing litigation or litigation strategies, and I do not intend to say too much on the topic now.
But just to be clear, we fully intend to protect the proprietary technology that we have invested in and worked so diligently to create over the five or six years that we are working together here. And we will vigorously defend any claims made by others about their alleged intellectual property to the extent that such claims speak to undermine Antares."

(update) I like what I read. Thanks Loko for sleuthing

We know PM has been selling in Jan/Feb thank to the 10k. I think they are continuing and this is one source of pressure on PPS.

Another source is the extremely negative sentiment, at least on this board.
Picked-up by analytical software, this could be feeding the HFT machines with a nice signal for shorting.

The negative article was not very robust, but created nice negative buzz for the shorts to feed upon.

Timing of approvals usually depend largely of the authorities...
At one point we will have to decide if we want faster and small or slower and large (i.e. what do we want to complain about

Beware of management bonuses tied to share price, sometime it results in "chance" timing of increasing PPS before exercise and sale

Bonus set for 2014 seems aligned with creating shareholder value (2013 10k pp 69):
• 50% Lymphoseek:
of which 40% generation of specified revenue amounts derived directly from Lymphoseek during fiscal 2014,
of which 5% approval sNDA for head and neck cancer,
of which 5% initiation of ex-U.S. commercial launch activities in select countries,
• 10% target enrollment in NAV4-02 Phase 3 trial for NAV4694,
• 15% target revenue from ‘business development’ sources such as in-licensing or partnering milestone payments,
• 5% Phase 1 or later initiation for a Manocept platform product candidate,
• 20% discretionary.

Sale of new shares is always in the air with biotechs, that is the name of the game until you become cash flow positive:
You raise cash to get to the next milestone, at which point the company value has increased and you can raise cash at a higher valuation, thus not diluting, to get to the next one, and so on...

Navidea warrants (2013 10k pp F-22)

Dec 31, 2013, 4,543 warrants outstanding at $3.39 average ($1.97 to $3.83 per share).
Included are Crede's 3,169 and none of the other belongs to PM.

Even adding the 391 at $1.918 to Oxford in Mar 2014, the total is 4,934 at $3.261 average.
As all are out of the money I don't see them exercised, and even so their impact would be minimal due to their small number.

Note CS outstanding is 149,703 on Feb 28.

Crede's warrants conversion results in maximum 3,839 CS (at $2.00 or below), with a minimum of 2,005 (at $3.83).
I don't see Crede selling below $2.00, as it would be ringing a loss.

Regarding PM, there are 3 things we know and 1 we don't:
-- High level change is ongoing at PM
(2013 10k pp 60) Michael Goldberg has served as a Managing Partner of Montaur Capital Partners since January 2007.
(2013 10k pp 84) Dr. Goldberg has advised the Company that he is in the process of completing his withdrawal from any ownership or management position with Platinum, but he has not advised the Company of the terms or timing of such separation.

-- PM's average cost
(13D/A dated Nov 13, 2013) 10,073 CS for $9.9 M and 26,199 (CS in Ser B) for $12.1 M
So, CS at $0.61 average.

-- PM has been selling since Nov 2013
(2013 10k pp 84) As of February 28, 2014, PM owned 14,185 CS and 11,128 CS in Ser B
So 10,959 sold Nov 13, 13- Feb 28, 14.

-- What we don't know, and alas is most important, is why PM is cashing out now.
One could assume by default this is Navidea-related and thus heralding horribly bad times.
We should also consider this could be Navidea-independent, linked to PM's fund-raising (cashing-in to generate ROI), fund-winding (cashing-out to pay LPs), or plain change of strategy.

JMHO

Let's not mix basal insulin (once-a-day to once-a-week) and prandial insulin (once-a-meal), as their physiological role is different.

Diabetics must often switch oral drugs because of failure of treatment.
Initiation of treatment is with cheap generic metformin, but add-on such as Januvia/ Forxiga/ etc... are not the same price.

As intensification of treatment and insulin use becomes necessary, Afrezza has a place vs. injectable insulin.
Also, one can imagine Afrezza allowing earlier use of insulin, which many physicians consider as THE treatment, thus using Afrezza instead of switching/ adding-on another oral.

Good points. I prefer for them to be actively involved in the future

Any news on the Gonella, Wotton, and Apple fronts ?
Would reinforce this positive.

From previous discussions, it seems that Crede is at least positive on the CS.
They, like us, are not in the business of earning bonuses by losing money...

We know PM has sold in Jan/Feb, and this did not sink the PPS.
As the shorts have not covered (directly), this means buyers are quietly lining up. IMO

Crede believed enough in the company to invest $30 M in it.
It appears their financial wizards calculated the ROI mostly on the options/warrants, with the quick flip of the CS as an entry to the deal.
Recall, they still have $7.7 M at risk and they convert at $2.00 minimum.
Unless they want to make a negative to ST treasury-like return, they cannot be selling immediately. JMHO

I have been thinking the same, noting:
- Wellington joined us in q4 with 3,101 new,
- Commerzbank tripled in q4 to 3,000 now,
- Susquehanna added 1,000+ in q4 to 1,033 now,
- Catalyst Capital joined us in q4 with 790 new,
that is 6,700 added in q4.

- short interest stayed flat since Nov 15 at 18,200-18,900.

Gorillas joining in parallel to PM selling is a good normalization of the shareholding structure.
q1 filings will be interesting to read.

Will we have this Summer hit movie: Gorillas vs. Shorts

Welcome to the dark back rooms of the shiny, beautiful pharma world.

I agree Medac filed its application before Antares.
The key question is if Medac can receive a patent on subject matter that would block Antares and stand in court.
As per the Medac lawsuit, they think so.
The problem is now if Medac's patent is valid.
Even us, ignorant laymen, have found relevant articles that could question its validity...

Finding Medac's 231 application (2010/0016326) mentioned in Antares' 631 is positive as it means the examiner considered it and still granted the patent.

Regarding spendings, don't forget Antares also have spend money developing Otrexup...

Patenting needs something to be patentable by law, novel, useful, and non-obvious.

You can patent drug substance, formulation, method of use, method of delivery, and manufacturing process.

I have no doubt Antares already has something cooking to actively protect Otrexup.
They are already battling Medac in Europe...

I think the patent examiner might have been a bit lenient with Medac.
As Rymankoly pointed in post 3074, prior art already exist...

looks like tit for tat possibly aiming at quid pro quo

Feb 28: Antares files patent infringement against Medac, following NDA filing

Mar 11: Medac files patent infringement against Antares

over $2.00, every penny increases Crede break even by one penny

CS exchanged = $7,669/ PPS
Initial 3,169 warrants at $2.423 deemed price

2.00 n= 3,835
2.01 n= 3,815
2.02 n= 3,797 chg approx 18,000

2.42 n= 3,169
2.43 n= 3,156 chg approx 13,000

3.00 n= 2,556
3.01 n= 2,548 chg approx 8,000

3.82 n= 2,008
3.83 n= 2,002 chg approx 6,000

Look again:
- lower interest rate:
8.5% vs 9.8% resulting in same annual expense ($2.6 M annually vs.2.5 M for GE) despite higher amount.

- reset interest only period:
Navidea was to start GE principal payment of $806/month on Jul 01, 2014.
Oxford give 1 y, with possibility of 2 additional ones depending on milestones, so we go to Mar/Apr 2015 at least.

- no negative financial covenant
free currently blocked cash.


The penalty for prepayment is 6% or $1.5 M.
So, it is a net $3.5 M extra cash, keeping interests costs the same.

We will know more once the filing is made.

A good reason might have been to keep the lights on for the shareholders till the next inflexion point...

32.9 M cash Dec 31 - 30 M Crede - 25 M GE = Chapter 7

They can sell any time they fancy, so can you, so can I.

Crede can reduce their exposure/ money at risk thru financial engineering and quick flip, but they still need PPS to go up to make real money.

Recall that the options/warrants have a deemed cost of $7.8 M and that TVM on it started Sep 24.
Selling immediately post conversion would mean no ROI on $7.8 M, and, even worse, a negative to nil IRR over 6 months.

This is why my guess is a quick conversion post Mar 24 to have a PPS as close to the $2.00 minimum as possible, followed by holding until PPS increases by at least 50-100%.

Whatever their price target, the selling pressure will be much lower than last Fall:
- They will only have 2.0-3.8 M CS to sell vs 10.6 M last time.
- As everybody now knows Crede's willingness to sell, panic will not so easily set up when they hit the market, as we will immediately consider the increased flow just Crede exiting.

Even earlier... Recall, Crede's minimum conversion is $2.00.

Crede is like us, it wants to make money not lose it.

If it had no faith in the company it would not have put any money in it: Putting $30 M in play shows confidence.

Financial engineering and quick flip can reduce your exposure/ money at risk, but you still need PPS to go up to make money.

Part of a divorce settlement, same as prior one last month.

Don't forget to read the fine print at the bottom of the form...

"Explanation of Responses:
1. Transaction occurred pursuant to a Rule 10B5-1 Plan entered into as part of a divorce settlement."

Short data published wed Feb 26 at 16h, according to Nasdaq.
We will have to wait a bit longer before satisfying our curiosity.

Just 2 small add-ons to IOU's:

HN would be 1st treatment on label, sulfur colloid is only indicated for BM.

SLN detection data, in particular the impact on surgery procedures and patient aftermath of less nodes removal (with average 4 vs 38 in HN) would be a convincing argument for use.