I am not sure of Medac's dry power capacity...

My estimate for Medac sales is around $475 M (Eur350 M) in 2013, with 900-1,000 employees.
It seems to be focusing on generics (mostly injectables) principally in oncology (since 1970), with recent pushes in autoimmune, urology, fibrinolysis, and reagents for diagnostics (mostly infectious), in Europe.
Not the highest margin business to generate cash...


This being said, I feel ATRS to be pretty cheap at the current $200 M EV, so I would not be surprised that some serious sniffing around is happening.

The take-over path jbr describes is typical of what I have read in past prospectus seeking shareholder approval.

Thanks for the insight. Connecting dots is much harder and requires more reflexion than writing "POS" without any support.

Those of us that come from the biotech/pharma side will agree with you that Term Sheets and Draft Agreements have been exchanged, even more since April's EMDAC.

Although we are all impatient, a delay between approval and signature is normal and of no concern:
- First, interested pharma parties would want to see the final communications from the FDA.
- After studying them, they would be ready for a big meeting hammering any leftover DD questions.
- Then, the final negotiations and contract writing would need to take place... And count on lawyer to bill their hours

This is the way things work in pharma.
It could be faster depending on the sense of urgency in the big pharmas involved, but you never know.
It is always better when dealing with them to manage expectation toward slower movement.


For those that PM'ed me, note that I cannot respond to private message, but I much appreciated the sharing.
TOS have been clarified for me too...

Due to the Mylan-Teva agreement, I have doubt about a launch of Vibex epinephrine before Jun 2015, but we don't know of "certain circumstances".
The good thing is that the Epipen IP protection goes into 2025 according to the Orange Book, which should give Teva/ Antares room for sales in the auto-injector segment.
Anyway, we should expect revenue from Teva's pre-launch stocking in 2014.

2013-10k pp 80:
"On April 26, 2012, the Company announced that Meridian Medical Technologies, a Pfizer subsidiary, entered into a settlement agreement with Teva that will resolve pending patent litigation related to its ANDA for a generic epinephrine auto-injector. According to the terms of the settlement, Teva may launch a generic epinephrine auto-injector covered by its ANDA on June 22, 2015 or earlier under certain circumstances, subject to receipt of approval from the U.S. Food and Drug Administration. Additional terms of the agreement are confidential.

Under a separate agreement, Teva has agreed to provide the Company with device orders of an undisclosed amount in the years 2013 and 2014, to make a milestone payment to the Company upon FDA approval of epinephrine auto-injector, and to assume all litigation costs related to the patent litigation between Teva and Meridian Medical."

2013-10K pp 18:
"Vibex® with Epinephrine ../.. In 2013, we made initial sales to Teva of pre-launch quantities of this product totaling $6.2 M."

2014-q1 pp 17:
"Product sales in the first quarter of 2014 also included $336,000 of sales of pre-commercial pen injector devices to Teva."

Positive buzz will eventually change the momentum

Currently negativism is in charge: Whatever the company does and whatever the products show is always crushed by negative PPS momentum that create fear in retail and generalists and void any positive news.

Still, I am encouraged by what is happening.

The key starting point to change the momentum is increasing LS sales.
I see EU approval as a milestone, as it would finalize the partnership there (possibly with upfront cash) and, obviously, further sales globally.
Regarding non-traditional LS uses like HN and other cancers, I see thew sNDA in Oct as another key one.
Developing new markets takes time, so far the trend has been on our side, but obviously we all want to see the sales...

On the rest of the pipe, I was encouraged by the JV: The company announced the R&D reorg saying something was in the air, and shortly thereafter there is R-NAV.
I like the JV with option to reacquire. This gives NAVB shareholders access to additional value if it works as expected.

As always, the next quarterly will be interesting.

Short attack today, 1 hour before Jul 15 numbers showing increased short interest means covering.

Look no further for reasons behind today's bear read...

At 4 PM today, Nasdaq indicated short interest increased by 3.9 M after Afrezza's approval. The bear attack started at 2:30 PM.
Recall settlement on Mon Jun 30 meant trade executed before Thur Jun 26 to allow for 2-3 days settlement, so before Jun 27's Afrezza's approval...

Clearly, some wanted to cover before it was known....

Settlement Date Short Interest Avg Daily Share Volume Days To Cover
7/15/2014 - - 71,777,133 - -- 8,642,379 - - 8.305252
6/30/2014 - - 67,874,816 - - 14,447,082 - - 4.698168
6/13/2014 - - 69,425,357

Recall Juergen Martens has divorced and has been selling as part of divorce settlement, as has been indicated in the notes of the form 4.

If at first you fail, try to hit harder with the same arguments till generalists and retail flee in fears seems to be some shorties' motto:

"The letter notes how a similar product, Pfizer's Exubera, was a failure and Afrezza is even more likely to flop given strong negative warnings on its labels, including one about the potential for lung cancer. It also notes that Afrezza will be more expensive than standard insulin injections."

"While Exubera has previewed what will happen with Afrezza, the market has had a way of ignoring this drug's past failures until it actually launches," the letter added. "When and if this happens, we believe that MannKind will ultimately trade down 90% to a value around $500 million or $1/share."


These have been debunked time and again:
- Exubera's size, cost, uneasiness of use compared to Afrezza.
- Cancer scare dating a few years for long-lasting insulins.
To be addressed in Phase 4 in a population at greater risk than the general population. If it were that bad, would the FDA put 8,000 with 3x the risk of cancer as the general population in danger ?
- COPD and asthma patients never target population of inhaled drug delivery.

Unless you are an ETF, a fund can always over- or under-weight a stock to generate alpha.
Navidea holding by ETFs don't seem to be large. So, it must be active funds.

ETF finder
% of ETF
IWC --- 0.06%
EWRS -- 0.03%
IWO --- 0.02%
URTY -- 0.01%
UWM --- 0.01%
IWM --- 0.01%
TWOK -- 0.01%
UKK --- 0.01%
VHT --- 0.01%
IWN --- 0.01%

IWC — iShares Micro-Cap ETF
Net Assets: $904,438,640 x0.06% = $542k = 400,000 shares (at $1.35)

IWO — iShares Russell 2000 Growth ETF
Net Assets: $5,614,785,123 x0.02% = $1,123k = 825,000 shares

For our education, a good explanation of the FDA policies behind the denial of Antares' Citizen's Petition by FDA Law Blog:

FDA’s Intervening NDA Approval Policy Strikes Again; Agency Denies Antares Petition on Methotrexate

How does one become a moderator ?
I notice that Trash-Talking F-15 is moderator for Mannkind ?!?!?!?

How does a moderator get removed ?
Trash-Talking F-15 is doing such a great job Yahooing this board !


Thank you I-Hub for the "ignore" button that I have just selected for Trash-Talking F-15 !!!


I have no problem with different opinions. I just can't stand trash talk for the pleasure of talking trash.

Your idea to correct the point some make that these Forms 4 represent insider purchases is good.

These RSU and performance-based options were linked to the following company milestones: Mannkind CRL response filing (Oct 14, 2013), my guess: Mannkind CRL response acceptance (Nov 21, 2013), and obviously Afrezza approval (Jun 27, 2014).
For more info on these see 10k 2013 pp 100-104: Note 12. Stock award plans.


Still, I beg to differ with "many sold all or a chunk of them".
The great majority of "sales" are in fact "Shares withheld to satisfy the tax liability to the vesting of a restricted stock unit award." (Note 2 of all form 4s)


Thank you for helping correct the misinterpretation of these forms 4 !

Read the form 4 carefully, else one might think you have an agenda...
The forms have more than 1 lines and they all have notes.

"Thomson acquired 30,000 shares @ $1.69 and sold all at $9.41
Pfeffer acquired 229K shares @ $0 and sold them all at $10
Dianne the "disposal queen" Palumbo sold hers too.
Juergen acquired 247K @ $0 and sold 120k @ $10. "

Thomson
The guy receives 247k RSU (note 1) with 129k withheld as tax liability (note 2) for a net 118k RSU, plus 410k stock options (notes 4-7), and you make a fuss about its 10b5-1 sale of 30k (note 3)?

Pfeffer
229k RSU (note 1), 129k withheld as tax liability (note 2)
Where did you see the last 100k being sold at $10 ?

Palumbo
The lady receives 118k net RSU (note 1 and 2), plus 410k stock options (notes 5-8), and she becomes a "disposal queen" because of its 10b5-1 sale of 18k (note 3 and 4)?

Juergen
247k RSU (note 1), 120k withheld as tax liability (note 2).
Why is this negative ?

Glad to read someone going a bit deeper than just plain bashing... I was starting to fear this board had become an extension of Yahoo's.

This arrangement is a good way to continue developing a program outside your balance-sheet while having an option on it in case it is successful.
Thinking about it, for $1 M over 24 months + $500 k in-kind services, Navidea owns 30% of a joint-program (no pun intended between Manocept and tin137 around RA, with an option to acquire if successful.
Obviously, the acquisition costs will be non-negligible. But that is the same for all such arrangements.


Tin117 is being developed by Clear Vascular, which has been backed by Essex Woodland since inception:
Clear Vascular

If you look at the science behind tin-117, it seems a smart match:
- imaging capability very similar to gamma photon imaging of Tc99
advantages: Navidea knows Tc99 and imaging capabilities readily available.
- conversion electron therapeutic with an ultra-short maximum range
key advantage: precision therapeutic (Manocept) + minimal off-target effect (Tin-117 CE ultra-short range)
I like the potential I am seeing...

"The gamma photon energy of tin-117m is 0.158 MeV and is very similar to the 0.140 MeV gamma photon imaging capability of the routinely used imaging isotope technetium-99m. This gamma photon of tin-117m can be imaged using standard gamma cameras and collimators found in all inpatient hospitals, outpatient imaging facilities and most private cardiology practices.
The conversion electrons (CE) from tin-117m are particle emissions with energies ~0.14 MeV that interact therapeutically with tissue. However, unlike the beta rays found in most therapeutic radioisotopes, tin-117m CE are mono-energetic and have a maximum range in tissue of slightly less than 300 microns, limiting its therapeutic effect to the desired tissue without damage to adjacent healthy tissue."

The Medac business has been painful and has created a lot of uncertainties which fed Momo players' vicious cycle.

If you look at the chart, Medac Jan 27 PR on Rasuvo filing was essentially shrugged off, but the fall started really with Medac Mar 11 PR on its new MTX patent and its pursuit of Antares for infringement.
The latest bout started with Wotton's surprise departure on Jun 24 and has continued into the approval of Rasauvo on Jul 10.

Having a competitor sneak one on you is quite painful !!
Antares has had to face 2 negative occurrences in the recent past in the denial of preliminary injunction (Jul 09) and the approval of Rasuvo (Jul 10).
I believe the denial of the preliminary injunction against Medac does not mean BD's physioject does not infringe Antares' patents because I believe the burden is different between a preliminary injunction and a trial (please correct me if I am wrong).
So, the field is not yet wide open to competitors...
I am expecting more clarification on the legal situation in the near future.

Commercially, after looking at the prescribing info for Rasuvo, I think Otrexup has a few aces up its sleeve (see my post 3417).

Hopefully, we should learn more during next month's q2 results.

Please do. Thanks for asking first.

Looking at the prescribing information for Rasuvo and Otrexup, I think Otrexup has a few aces up its sleeve compared to Rasuvo, which, with the head-start on launch, should keep it ahead commercially.

Antares has mentioned a 25 rep salesforce while Medac is recruiting 27 reps. But, Leo has a 75 rep salesforce for psoriasis, which gives an advantage to Otrexup.
Antares will have at least an 7-8 months head-start (mid-January Otrexup launch vs. Sep/ Oct Rasuvo launch, as Medac needs time to recruit and train its new salesforce).
Added to the differences in products characteristics, this should give an advantage to Otrexup.


The prescribing information is essentially the same boiler-plate for both, but some differences exist, in particular in the User Instructions part:

1 - shelf-life:
Rasuvo's is 17 months.
Otrexup's is 24 to 33 months (24 for 10/15 mg and 33 for 20/25 mg).
= At least 7 more months before need to be returned or thrown away.

2 - dose-strengths/ SKU:
Rasuvo has 10 going from 7.5 to 30 mg in 2.5 mg increments.
Otrexup has 4 going from 10 to 25 mg in 5 mg increments.
= Not sure if 2.5 mg increments would really change the life of rheumatologists and patients vs. 5 mg ones.
= Not sure if 27.5 and 30 mg doses critical vs. 25 mg.

3 - PK/ Bioavalavility:
Rasuvo: healthy subjects, 7.5 to 30 mg exposure 35 to 68% higher than oral MTX; psoriasis, 30 mg exposure similar IM.
Otrexup: rheumatoid arthritis patients under oral MTX for at least 3 months, 10 to 25 mg exposure 13 to 36% higher than oral MTX, also similar abdomen or thigh.
= Not sure if one is better than the other in absolute. Still, I think a rheumatologist would find RA data in patients already under oral MTX more pertinent.
= Note “significantly enhanced bioavailability” was highlighted by Medac in this morning’s PR.

4 - Needle visibility:
Rasuvo has a visible needle.
Otrexup neddle is hidden.
= Needlephobia could have influence in patients using a non-oral drug for the first time.

5 - Device activation:
Rasuvo: pull bottom cap straight (do not twist), push firmly against the skin to unlock safety.
Otrexup: twist bottom cap, flip top safety clip.
= Not sure if significant other than the two modus operandi are not exchangeable.

6 - Injection-site preparation:
Rasuvo: clean, "pinch a pad of skin with your thumb and forefinger of your free hand by gently squeezing. Patients with rheumatoid arthritis who are unable to pinch the skin can inject directly into the thigh without pinching if needed."
Otrexup: clean only.
= Otrexup simplest.

7 - Injection:
Rasuvo: press top button, once click heard count to 5.
Otrexup: push firmly till click heard, count to 3.
= Not sure if significant other than the two modus operandi are not fully exchangeable.

Taken together, 5- device activation and 7- injection seem easier for Otrexup.

I have to tip my hat to Medac: That was a sneaky one !
They made good use of the advantage of being private and of loopholes in FDA regulations...

The legal fight not being over, you make a great point of Medac having to decide of potentially launching at risk or not.
I have had a quick look, and it seems the burden is different between preliminary injunction and trial. Looking forward to your opinion JoeB !

I found interesting the wording used by Antares in this morning's 8k:
"Antares believes in the strength of its intellectual property and intends to vigorously prosecute its litigation claims. The litigation is expected to proceed to a jury trial unless settled by the parties; a trial date has not been set."
Maybe I am reading too much, but the last sentence seems to leave negotiations open, as many companies would have stopped after the first.
All the more as the timeline for Medac v Antares is rather long: next conference call on status on Oct 14, 2014; schedule proposal to Court by late Feb 2015 regarding claim interpretation (Markman hearing) if needed; last deadline post discovery scheduled late Nov 2015...


The positive is that now 2 sales forces would work on developing the market, as Medac is hiring 27 reps.

Very interesting comment from Judge Robinson.
If a "plain" judge can see that, I wonder what the FDA will think of it...


How do you think this links with the mediation conference from yesterday ?

From your quote on preliminary injunction, it seems it rather was to be expected. So, the show must go on like sang Queen.

old news, short data for Jun 13 settlement date

The new one for for Jun 30 settlement date is only coming out this Thursday (Jul 10) at 16h.

Question: Would Mon Jun 30 settlement include Fri 27 approval trades or stop at Wed 25 or Thru 26 trades (typical 2-3 business days to settle) ?

This will be useful when reading the upcoming comments about the Jul 30 number.
My guess is that the short number will be flat-ish to slightly increasing, as approval was faster than expected and the gyrations from Friday afternoon should not have made it thru yet.
(added in edit) The real changes will be seen in the Jul 15 settlement published on Jul 24.

Here is the site for the guy who wrote it: Richard Pearson
Mox Reports: Behind the promotion of Northwest Bio (NWBO)

I think this is a good education on the manipulations that sometime happen. The guy investigates pump, obviously the same happens for dump. I have seen too much of the SA, AF, etc... effect on stocks with low institutional holdings...

Finally, a must read Seeking Alpha article: "Behind The Promotion Of Northwest Bio"
http://seekingalpha.com/article/2301825-behind-the-promotion-of-northwest-bio

About undisclosed paid promotion, message boards, and fake aliases, with a few company names...

This is about pumping. Obviously, this would never happen for dumping.

And I thought all participants on MB, SA, The Street, etc... were neutral, fact-grounded persons. I am really falling from high.


Like the romans were already saying: Caveat Emptor

Frisking for loose money ?
Come on, this is only a mediation conference on MTX.

Not a lawyer, I come from the biotech side.
I have worked in close collaboration with patent attorneys in prosecution and challenge for a number of years.

Getting back into the law, trying to get a good grasp of the current situation.

If Medac’s Rasuvo infringes on any layer of Antares’ IP estate, it infringes that’s all that matter.
So, to be free to commercialize Rasuvo, Medac must not infringe any of the 2 layers: neither the general umbrella nor the MTX-specific one.
In the amended complaint filed by Antares on Apr 18, Antares complains of infringement of 4 patents. My read is that some are general and some are specific to MTX.


Regarding my statement, recall this was in the context of what I perceived were your fears regarding other products than MTX in case Medac gets something regarding Rasuvo.

I am not sure what the separate 2 other points are. Could you clarify ?

Antares position is NOT weak.
I gather from your post you fear that if Medac gets anything out of the current Otrexup/ Rasuvo situation, then Antares is finished as a company.

Fear not. We have 2 linked but separate situations on auto-injectors: MTX and general.
Antares has 2 levels of protection on auto-injectors and their use: the first is a general umbrella, the second is a subset specific to MTX.
So, even if Medac could commercialize a MTX auto-injector, Antares would still have the umbrella IP on other auto-injectors, in addition to ones specific to each molecule or use.

It seems Antares could have a 3 year exclusivity from the FDA (see b 4):
21 cfr 314.108 New drug product exclusivity
Intriguingly, the Orange Book shows none.

Bio-P, a big difference between 505(b) and 505(j)/ANDA is that 505(b) gives you 3 to 5 years exclusivity (cf. above) while ANDA gives only 180 days at the utmost for the first to file.

TDpete, I believe Orange Book patents are only important with regard to patent information required in an application not FDA exclusivity (see i):
21 cfr 314.50 Content and format of an application.
This is the point of Antares' Citizen Petition.
My read is that even if this information was not available at the time of submission/ receit/filing, as Antares is obliged to file it under 314.53, Medac is obliged to update its application as new patent information becomes available.
This allows a bit of public muddying as Medac would not be lying at the time of mailing its application...

My thought when I initially saw Medac's patent was of its going for a quid pro quo with Antares.
But, looking more at this patent in view of all the Antares ones listed (expiring in Aug 2019 or Mar 2030 with regards to use for SC injection MTX), I think like JoeB that Antares is playing from strength.
I don't know if they would decide to roll the dice on jury or would settle. Still, like you, TPpete and JoeB, I think the latter is probable.
Anyway, the more I read about the FDA act, the more I am convinced a settlement would not be a plain quid pro quo, but that Antares should gain some exclusivity from Medac.
Off hand, I would think until expiration of the first use patent (Aug 2019) would be fair. (I admit to a certain bias toward Antares

TDpete, nobody gets 20 years of exclusivity on the market as patents only have a 20 year life.

True, patent infringement starts at submission of 505(b)(2) application:
(e)(2) (A) "It shall be an act of infringement to submit an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent,"
35 U.S. Code § 271 - Infringement of patent

The question is what constitutes "submit an application".
I am no lawyer, but know enough to know words sometime have different meanings in law...
Hence my questioning if submission is the date of mailing of the application (like taxes), the date of receipt by the FDA, or the date of acceptance of filing by the FDA ?


Also, I was wondering about the FDA when musing about Nov 09 and Sep 10, 2013 in view of Otrexup.


Great discussion TD and Joe !

I love it when (possible) future events are already counted as if they had already happened, without clearly stating so, in the $5 B headline number:

"We know that upon approval, all the executives will receive huge amount of shares. On top of it, I don't know if DF dilution is included in the above 377 mil its total of $100 mil dilution attributed to DF deal. + $50 Mil ATM, + invariably Al's remaining credit line will be used and converted to shares - so additional $30 mil dilution"

I looked a the latest entries in Antares vs Medac (case 1:14-cv-00270).
In doc 77, "ANSWER to Amended Complaint, re: 27 F Amended Complaint with Jury Demand , COUNTERCLAIM against Antares Pharma Inc. by Medac GmbH", filed Jul 01, 2014, Medac writes:
(parag 11) "medac admits that the FDA accepted medac Pharma's NDA for filing pursuant to 21 cfr 314.101(a) on Nov 09, 2013"

So, the date of receipt of application is Sept 10, 2013 pursuant to 314.101(a)(2) "../.. The date of filing will be the date 60 days after the date FDA received the application.”
Thus, the initial PDFUA target date of July 10, 2014 is fully explained.


As Otrexup was approved on Oct 11, 2013, the question for the FDA seems to become which of Nov 09 NDA filing date or Sep 10 application receipt date is more important in reviewing Rasuvo.


Regarding review periods, I must admit I got confused and mixed-up CFR and PDFUA.
If ideally, the Code of Federal Regulation aims at a 6 months initial review, in practice, the Prescription Drug User Fee Act aims to review and act on 90 % of standard non-NME original NDA submissions within 10 months of receipt (I.A.3.).

PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017

Medac is developing Rasuvo as 505(b2) not regular NDA
(Medac) Drug Approval Pathway

Under 21 CFR 314.100- Timeframes for reviewing applications and abbreviated applications.
(a) ../.. within 180 days of receipt of an application for a new drug under section 505(b) of the act or an abbreviated application for a new drug under section 505(j) of the act, FDA will review it and send the applicant either an approval letter under §314.105 or a complete response letter under §314.110. This 180-day period is called the “initial review cycle”.

Under 21 CFR 314.101- Filing an application and receiving an abbreviated new drug application.
(a)(2) ../.. The date of filing will be the date 60 days after the date FDA received the application. The date of filing begins the 180-day period described in section 505(c) of the act. This 180-day period is called the “filing clock.”

So, Jul 10, 2014 PDUFA date - 180 days = Jan 10, 2014 date of filing - 60 days = Nov 10, 2013 date of receipt.
Hence Medac's submission is post Otrexup approval.

He just forget to mention the status of the competing inhaled insulins...
Details, details, as we all know it takes no time to develop and get approved a new insulin product, which might be a pre-requisite first step before "applying pricing/margin pressure and putting MannKind out of business."


Anyway, with a somewhat negative tone and a (very) weak mention of possible opportunities for long, whatever happens, he could say he predicted.

I think I should consider a subscription to the Street to get quality manure for my garden...


"Richard Saintvilus is Founder and CEO of WallStPlaybook.com. After 20 successful years in the IT industry, Richard Saintvilus decided his second act would be as a stock analyst-bringing logic from an investor's point of view."

Shorts are out with a vengeance today...
One can see that Mankind has left the Circuit Breaker List (limiting shorting) where it was yesterday.

-- conjunction with needles:
As you don't know, insulin has both basal and prandial patterns. Afrezza is a prandial insulin and would not replace basal injection in patients in need of, such as type 1.
Still, in the treatment algorithm, once failing orals a patient could add Afrezza instead of going basal injection. Oops, this is a new markets...

-- smokers+ pot smokers+ asthma/copd= 30-60% population:
Laughing too hard to respond. It must be the smoke...

-- inhaled insulin failed once already:
Thanks for bringing back Exubera, Halloween has in come early this year. Happy Halloween ! (Isn't it a bit too warm ?)

-- Black box warning:
Many very enlightened responses written already.

-- No revenue:
Duh, approval was last Friday...

-- No partner:
Duh, approval was last Friday...
Needs a bit of time to present the latest FDA discussions to potential partners, then haggle a bit (and raise BP bids for everybody but shorts' benefit), then lawyer a lot, before CEO signing.

Straight from the horse's month, the way I like. Thanks !

I got the feeling Medac has been back-filing the news section of its website recently...

I did a bit more digging, and the initial review cycle response should be within 180 days from the date of filing (and not 9 months as in the outdated doc I initially looked). So official date of filing should be around Jan 10, 2014.
So, it would seem Antares has a point with its citizens petition to the FDA regarding improper Reference Listed Drug and patent certification.

Anyway, we should see shortly.

PDUFA date for an application filed in January 2014 would fall on Jul 10, 2014 as per your post ?
6 months only while 505(b1) and 505(b2) have targets of 9 months ??

This also, with Antares' citizen petition requesting Otrexup as Reference listed drug (RLD) in the air ?

Where do your dates come from ?

MNKD on SEC Short Sale Circuit Breaker: shorting still allowed.
Limitations if price below $9 (10% of Friday close).

see post 4244

MNKD on SEC Short Sale Circuit Breaker Monday June 30:

Will complicate the life of shorties. BEWARE, shorting still allowed.

Short Sale Circuit Breaker


Reg SHO FAQ

"In accordance with SEC Rule 201 (Alternative Uptick Rule), NASDAQ, BX and PSX will make changes to systematically prevent the execution or display of a short sale order with respect to a covered security at a price that is less than or equal to the current national best bid if the price of that security decreases by 10% or more, as determined by the listing market for the security, from the security’s closing price on the listing market as of the end of regular trading hours on the prior day (“Trigger Price”)."

even better, simply for diabetes mellitus: this means all forms of diabetes: type 1, type 2, gestational (pregnancy), ... are included !

Key is no pulmonary testing required... Exhubera had one !

Asthma and COPD, same as Exhubera and not surprising.

Official: FDA approves Afrezza to treat diabetes

FDA approves Afrezza to treat diabetes