Nabriva Therapeutics PLC (NBRVF)

[chitre]

Will have to wait for next Wednesday 29th to see what develops on that vote.

Hopefully positive.

[chitre]

Nabriva Therapeutics (NBRV) Catalysts
Merck collab: https://www.globenewswire.com/news-release/2020/07/15/2062852/0/en/Nabriva-Therapeutics-Enters-into-Exclusive-Agreement-to-Promote-and-Distribute-SIVEXTRO-tedizolid-phosphate-in-the-U-S.html Announced after hours yesterday
For comparison: Surface Oncology (SURF) announced a collaboration with Merck on May 20. Price hovered around $2.3 and jumped to a high of $7.66 at this time. That’s over 100% on this collaboration news alone with Merck. So plenty of upside left for NBRV
An EMA (Europe) approval for this same medicine (Lefamulin). Deadline this month. So news sometime this month.
Any positive news about their FDA approval for Contepo.

[chitre]

we have to hope the vote is no


Nabriva Therapeutics (NBRV) Risk
At the end of the month (29th of July) there will be voted for a reverse split, which might decline the prices. However, I think this is to prevent delisting from stock exchange. This will be unnecessary if the stock finishes 10 days in a row above 1, which is highly possible with this Merck collab news. I expect this to be cancelled before the vote, if not, the vote will be overwhelmingly no. this rs was scheduled way before the Merck partnership was announced.

[skitahoe]

You're no doubt right, it's the way all sort of companies operate when they don't have earnings. Dilution or a partnership are the only way out until they have a product approved for sale. I see that Nabriva does have one product approved, but I'm uncertain about sales, it sounds like they're looking to partner. Such a partnership would probably resolve all their problems.

I really don't know that much about the company, took a small position at the recommendation of a friend. If the R/S is approved, I don't know that I'll stay with it. If I remember correctly, the approval of a second drug is anticipated, but being held up by the FDA's inability to approve the production facility located outside the U.S. To my way of thinking if that's all that's holding it back, any idea why they've not gone for European approval. That could lead to the higher prices, perhaps a partnership, and I'd hope the FDA would agree to the European approval of the production facilities if it's an approved drug that they've approved the production facility for.

Gary

[savagess]

I would of hoped they wouldn't have diluted and with all the news the PPS would have stayed above $1 and proceeded higher. They are starved for cash so have massively diluted into all the news, the reason why this hasn't moved at all and gets knocked down after any buying pressure. They know a reverse split is coming and that will keep them on the NASDAQ plus allow them to continue the dilution process. That's what the crap stocks do.

The RS is pretty much a no brainer. What I don't get is why not had just let the PPS stay over $1 witch it would have if they didn't just keep printing shares. But then that gives others the chance to make profit and allot would be day traders and flippers not real investors. That's basically us! lol SO why would the allow that when they can get everything for themselves and feed of the suckers buying into the BS news or fluff.

Greed is an amazing thing! SO now the reverse split comes then the printing press can keep running full steam! The only thing positive I can say as at least no public or direct offering witch would of just come if the didn't dilute and do the reverse split. So at least anyone could get out nearly unscaved rather than a public offering and a huge gap down out of nowhere one morning.

I DO believe a Public or direct offering will definitely come after the reverse split, only a matter of time and if not, just keep printing shares anyway.

[skitahoe]

Dilution is a fact, whether at a higher, or lower share price, as long as a company is developing products, and not generating substantial earnings. I'm not that adverse to it when it's needed to maintain operation and not be starved financially. I don't want the R/S, I believe if it fails the price will exceed $1, and then they will probably dilute. As long as they stay above $1 for 10 days, they're qualified to stay on the Nasdaq another year, while I'd hope they didn't dilute to the point of taking it below $1, if they do they'll have time to build it back up.

Gary

[sick nam vet]

Same here,if the vote is no then I'll jump back in.

[savagess]

The split will most likely happen but you never know. If it does happen the PPS will likely continue to just slither down like most do. My other concern is a Public or Direct offering coming after the reverse to help continue the dilution.

[skitahoe]

I agree with most of what you're saying, but I've seen investors prevent several reverse splits, so it can be done. The key is getting all who read boards like this one to agree to vote no. I don't have that many shares, but it's certainly my vote.

Gary

[savagess]

I agree IF the RS got voted down this would spike up over $1 but I do not think the RS will get voted down. If it does, then congrats to the longs who held on and it should go even higher after the news if no RS.

[savagess]

If the RS was dropped or doesn't get voted in (highly doubt it though), I agree the PPS would go over $1 The thing is, I don't think the company cares or thinks like that, they just need to resume compliance and an RS is the easiest way to do it. No real skin of they're asses.

As far as the RS vote, as with most stocks in this price range management does usually have sufficient control that votes are just a formality they must go through.

The RS WILL go through. Then usually the dilution continues right back down to under $1 and lower as all these penny stocks are usually a scam. The "company" if you can even call it that makes NO real money, any money is made from feeding off the stock! Non stop DILUTION as suckers buy into news, usually bull shit or fluff.

This company actually seems to be a real deal but so far it doesn't look good. If everything is true, and the news on this company, it should not be trading under no dollar! Something doesn't add up and it seems like just endless shares have been dumped day after day and if you notice, anytime this tries to even move up a little, it gets slammed back down.

With a float supposedly of only 100 million shares, this should be way over $1

I see all the warning signs. I will just sit on the sidelines and see what happens after the RS

GLTA

[werd]

For the past month $O TX was @ .50-.60 and shareholders voted down RS. Hit 1.30+ this week. Vote no to RS!!

[skitahoe]

The question is, if the dropped the reverse split, wouldn't the share price run to over $1 saving the need for doing it. I believe it would, and it might very well do it if they lose the reverse split vote.

This would not be the first time I've seen investors turn down a reverse split, but I don't know how many shares management has control of. In some companies management has sufficient control that votes are just a formality they must go through. I don't know what the case is here, anyone care to comment.

Gary

[savagess]

NASDAQ compliance is the reason for the reverse, we all know that. Anyone know when the deadline is for compliance? They always seem to get voted in too. Some pull through a reverse but it is rare. After the RS I might look for a re-entry point but this seems to be a typical penny stock dilution machine. What also concerns me is at anytime a public or direct offering could be announced. That is my biggest concern with this after the reverse split.

[skitahoe]

I'd be willing to bet that if they abandoned the R/S the share price would go above $1 almost immediately, then they would have no reason at all to do it. I also believe that the Nasdaq is extending the deadline beyond a year, which is the normal if you request and extension, because of Covid-19. If they insist on bringing it to a vote, investors should vote it down.

Gary

[John-Knee]

I agree that R/S is bad for the stock price but there are a few stocks that made it through okay; Citi Group and Bank of America. They pulled through because of their underlining assets. NBRV have drugs selling in the open markets with others in the pipeline. The reason for the R/S is get their share price above listing rules. With the action lately and positive news, I would vote no on the R/S and let the price unleash upward. As others said, the lingering R/S pending is casting an overcast on the share price. Let’s see what next week brings us.

[savagess]

Ya, this was supposed to be my swinger but I got our today because i don't like those reverse splits. Who does? Kiss of death to continue the dilution machine and this is a HUGE one! I guess breaking even though is better than loosing. Now that I sold the dam thing will take off, seemingly the story of my life lately. I do better day trading and scalping. Just do the opposite of my swings and you will make good money! lol I will come back and have another look after the reverse.

GLTY

[sick nam vet]

Another reason it's trading down is the r/s vote pending in the 27th i believe or the 28th.

[savagess]

Unbelievable dilution. No other explanation for the non stop selling. Dropping like the titanic and LOD. Totally ridiculous!

[savagess]

[John-Knee]

Lefamulin Demonstrates Anti-Inflammatory Activity in Pre-Clinical Study
2020-07-23 07:05:03 AM ET (GlobeNewswire)
   
   
-In pre-clinical model, lefamulin shows anti-inflammatory activity comparable to dexamethasone

-Nabriva awarded grant funding from the Austrian Research Promotion Agency to further characterize the anti-inflammatory and immunomodulatory properties of Lefamulin

Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today the results of a pre-clinical study demonstrating potent anti-inflammatory activity of lefamulin. In a mouse model of lipopolysaccharide (LPS) induced lung neutrophilia, lefamulin showed anti-inflammatory properties similar to dexamethasone, a corticosteroid commonly used for its anti-inflammatory and immunomodulatory properties. Lefamulin, the company's novel pleuromutilin antibiotic, is approved by the U.S. Food and Drug Administration (FDA) under the brand name XENLETA(R) for the treatment of community-acquired bacterial pneumonia (CABP) in adults. XENLETA is the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades. The study was accepted as a pre-print manuscript in bioRxiv.

The research findings reflect the first study investigating the anti-inflammatory activity of lefamulin. In the mouse model of LPS induced lung neutrophilia, pretreatment with lefamulin at doses of 35, 70, and 140 mg/kg administered subcutaneously (SC) 30 minutes before intranasal LPS administration challenge was associated with almost complete reduction in total cell and neutrophil recruitment to the lungs at 4 hours post challenge compared with the vehicle control group (no treatment). Importantly, lefamulin demonstrated reductions in total cell and neutrophil counts that were similar to those observed with dexamethasone at all lefamulin doses tested.

Nabriva has also been awarded grant funding from the Austrian Research Promotion Agency (FFG) as part of their "Emergency Call for COVID-19" research. This funding will support additional in vitro and animal experiments designed to investigate and further characterize the anti-inflammatory and immunomodulatory properties of lefamulin, as well as our proprietary library of pleuromutilin compounds.

"The anti-inflammatory effect lefamulin demonstrated in this study is very encouraging," said Jennifer Schranz, MD, Chief Medical Officer of Nabriva. "Inflammation complicates several pulmonary diseases including pneumonia and contributes substantially to morbidity and mortality in patients. We are excited to partner with the FFG to further investigate the anti-inflammatory and immunomodulatory properties of lefamulin and its potential application to inflammatory pulmonary diseases."

Complete findings of the study titled "Anti-inflammatory Activity of Lefamulin in a Lipopolysaccharide-Induced Lung Neutrophilia Model" is available online at: https://www.biorxiv.org/content/10.1101/2020.06.23.168393v1.full.pdf. Additional details about the FFG and the emergency call for COVID-19 research can be found at https://www.ffg.at/en/news/corona-call.

About XENLETA

XENLETA(R) (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting.

About Nabriva Therapeutics

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). XENLETA was discovered in Nabriva Therapeutics laboratories in Vienna, Austria. For more information, please visit www.nabriva.com.

About the Austrian Research Promotion Agency (FFG)

The Austrian Research Promotion Agency (FFG) is the national funding agency for industrial research and development in Austria. The purpose of the FFG is to promote research, technology, development and innovation for the benefit of Austria. All FFG activities aim to strengthen Austria as a research and innovation center on the global market and thus help to ensure the long-term availability of high-quality jobs and maintain the prosperity of one of the world's wealthiest countries. For more information, please visit https://www.ffg.at/en.

[savagess]

Yet this is trading at .80 It doesn't make any sense.


Nabriva Therapeutics (NASDAQ: NBRV) is a Dublin, Ireland based biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva received U.S. Food and Drug Administration approval for XENLETA(TM) (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Xenleta is the first IV and oral antibiotic monotherapy treatment option approved by the FDA for adults with CABP in nearly two decades. Nabriva Therapeutics is also developing CONTEPO (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTIs), including acute pyelonephritis.

Nabriva Therapeutics plc recently announced an exclusive agreement to sell and distribute Cubist Pharmaceuticals' anti-bacterial medicine Sivextro (tedizolid phosphate) in the United States and across its certain territories. Cubist Pharmaceuticals is a wholly owned subsidiary of Merck. Sivextro is used to treat acute bacterial skin infections and was approved by the FDA. The financial terms of the agreement were not disclosed, but Nabriva will be exclusively responsible for marketing, sales and distribution of Sivextro in the United States until Dec 31, 2023 with renewable three-year extensions. Shares of Nabriva were up more than 50% following the announcement of the deal with Merck, but still trade 70% off of their 52-week high of $2.77.

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[savagess]

Chart looking good, poised for an upward trend and green Wednesday!

[sick nam vet]

Shorty working his azzz off to try and short this.

[savagess]

Don't see any past posts on you "calling it", unless it was posted in another chat room.

[MoneyMan931]

NBRV biggg movesss back to 4.60$ I called the 1.06 2weeks ago!

[TFMG]

$NBRV | #NabrivaTherapeutics Plc Targets



Nabriva Therapeutics Plc is a biopharmaceutical company, which engages in the research, development and commercialization of novel anti-infective agents to treat serious infections. Its product pipeline includes Lefamulin, and CONTEPO. The company was founded in October 2005 and is headquartered in Dublin, Ireland.

[ClayTrader]

* * $NBRV Video Chart 07-17-2020 * *

Link to Video - click here to watch the technical chart video

[Greenboat]

$6.00 coming soon!!! Buy buy buy!!!

[Greenboat]

Get ready for lift off!!

[shurtha2000]

Fools selling finally let up

[weedtrader420]

woohoooo <(8D) party hat

[maximumgriff]

Broke ass company!! POS

[shurtha2000]

who turned off the computers sheesh lite volume

[ClayTrader]

* * $NBRV Video Chart 07-16-2020 * *

Link to Video - click here to watch the technical chart video

[weedtrader420]

NICE looking good after hours $3 Target price

[John-Knee]

XENLETA(R) (lefamulin) Receives Health Canada Approval for Treatment of Community Acquired Pneumonia
2020-07-16 04:04:12 PM ET (GlobeNewswire)
   
   
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that its partner, Sunovion Pharmaceuticals Canada Inc., has received approval from Health Canada to market oral and intravenous (IV) formulations of XENLETA (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults. Additional information on the Notice of Compliance from Health Canada dated July 10, 2020 is available at https://health-products.canada.ca/noc-ac/info.do?lang=en&no=23888.

Nabriva entered into a license and commercialization agreement in March 2019 with Sunovion Pharmaceuticals Canada Inc. for XENLETA in Canada. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, is a wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc.

About Nabriva Therapeutics

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). XENLETA was discovered in Nabriva Therapeutics laboratories in Vienna, Austria. For more information, please visit www.nabriva.com.

About XENLETA

XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most frequently reported adverse reactions are administration site reactions (7%), diarrhea (7%), nausea (4%), vomiting (2%), hepatic enzyme elevation (2%), hea dache (1%), hypokalemia (1%), and insomnia (1%). Administration site reactions led to discontinuation in <1%; gastrointestinal disorders were predominantly associated with the oral formulation and led to treatment discontinuation in <1%.

[Gan]

wow.. $1.15 in PM to 0.80's now.. cant hold any gains..News was good but good for only 20% gains?

[altruism]

Bouncing off the upper 80's looks like a double bottom

[altruism]

.95 gone fast

[altruism]

Starting to bounce nice

[Aevora]

looking to make a Gene like move

[weedtrader420]

NBRV & MERCK WoW!

[weedtrader420]

Looking real good NBRV $3 TARGET PRICE TODAY

[weedtrader420]

Good news NBRV $3 TARGET PRICE WOOHOOOOOOOOOOOOOOO

[John-Knee]

Nabriva Therapeutics Enters into Exclusive Agreement to Promote and Distribute SIVEXTRO(R) (tedizolid phosphate) in the U.S.
2020-07-15 04:01:10 PM ET (GlobeNewswire)
   
   
-- Accretive transaction creates synergies and scale that strengthen Nabriva's community-focused commercialization organization to optimize product uptake

-- Nabriva partners with Amplity Health to provide community-focused customer engagement and sales initiatives for SIVEXTRO and XENLETA(lefamulin)

Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it has entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO (tedizolid phosphate) in the United States and certain of its territories. SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible Gram-positive microorganisms.

Ted Schroeder, Chief Executive Officer of Nabriva, commented, "We are excited to be selected by Merck & Co. Inc., Kenilworth, N.J., USA as their exclusive commercialization and distribution partner for SIVEXTRO in the U.S. This transaction is aligned with our corporate strategy to add revenue generating products to our business that benefit patients and create value for shareholders. SIVEXTRO is an excellent fit in our portfolio, with a highly complementary customer base, creating synergies and scale with our commercial team."

Patrick Magri, Merck & Co. Inc., Kenilworth, N.J., USA's Senior Vice President, Hospital & Specialty Business stated, "For more than 80 years, Merck has contributed to the discovery and development of novel medicines to combat infectious diseases, and we continue that commitment today by driving innovation in the antibacterial marketplace. We are pleased to enter into this arrangement which provides Nabriva with the rights to market, sell and distribute SIVEXTRO in the United States."

Under the terms of the agreement, Nabriva will procure SIVEXTRO from Merck & Co. Inc., Kenilworth, N.J., USA and be responsible for marketing, sales, and distribution of SIVEXTRO in the U.S. through December 31, 2023, with renewable three-year extensions.

Additionally, Nabriva has engaged Amplity Health, a leading pharmaceutical contract commercial organization, to provide community-based commercial and sales services for SIVEXTRO and XENLETA in the U.S.

"Our new partnership with Amplity Heath provides us the opportunity to build a flexible and scalable commercial infrastructure that enables us to optimize the uptake of both SIVEXTRO and XENLETA, while mitigating potential risks associated with the evolving COVID-19 pandemic. Amplity has the experience and depth to effectively educate prescribers about the appropriate use of both of these important antibiotics. We look forward to educating clinicians about the differentiating attributes of both products and bringing these important treatment options to patients," said Mr. Schroeder.

About Acute Skin, Skin Structure and Soft Tissue Infections (ABSSSI)

Acute bacterial skin and skin structure infections (ABSSSIs) are common and often require antibiotic treatment. According to the U.S. Food and Drug Administration (FDA), these infections can be uncomplicated - simple abscesses, cellulitis or wound infections mainly caused by the two most common Gram-positive pathogens, Staphylococcus aureus and Streptococcus pyogenes. They can also be complicated either involving deeper soft tissue or requiring surgery - such as ulcers, burns and major abscesses or involving a significant underlying disease state. ABSSSIs are at least 75 cm.

About SIVEXTRO (tedizolid phosphate)

SIVEXTRO was approved by the FDA in 2014. It is indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococcus faecalis. MRSA has been categorized by the U.S. Centers for Disease Control and Prevention (CDC) as a serious public health threat. SIVEXTRO 200 mg is administered once daily orally or as an intravenous (IV) infusion over one hour for six days.

[John-Knee]

WEP Clinical Partners With Nabriva Therapeutics for the Named Patient Supply of XENLETA(R) (lefamulin)
2020-07-06 07:00:01 AM ET (BusinessWire)
   
   
WEP Clinical (WEP), a specialist pharmaceutical services company, has signed an exclusive agreement with Nabriva Therapeutics (Nabriva) to supply XENLETA(R) (lefamulin) on a named patient or expanded access basis. The Named Patient Program (NPP) is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available.

XENLETA was discovered and developed by Nabriva (NASDAQ: NBRV), a commercial-stage biopharmaceutical company focused on commercialization and development of anti-infective agents. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. XENLETA is the first and only oral and IV pleuromutilin empiric antibiotic that acts against the pathogens that commonly cause CABP.

Nabriva announced on May 29th that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XENLETA for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. The CHMP opinion will be reviewed by the European Commission (EC), which has the authority to approve medicines for all 28 countries of the European Union, Norway, Iceland, and Liechtenstein. A regulatory decision is anticipated during the second half of 2020.

Under the terms of the NPP, XENLETA will be made available in two formulations - 150mg injection for intravenous administration and 600mg oral tablets - using named patient or expanded access managed by WEP to enable healthcare professionals to access XENLETA for patients that have an unmet clinical need. Once a request is approved, WEP will manage the distribution of XENLETA to the treating physician and will provide any necessary follow-up support and services.

About WEP Clinical

Established in 2008, WEP Clinical is a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available. We have offices located in the UK, US, Portugal and Ireland and possess all the necessary licenses allowing us to meet drug access and distribution needs across all regions, worldwide. We are passionate about helping those in need. For more information, please visit www.wepclinical.com.

[Olde English 800]

I agree with with everything you said there Gary. I asked the same questions.

[Rapture2020]

EU APPROVAL BY END OF JULY.

[Nealio]

Most likely the FDA is clinging to some of the usual government 'we've always done it this way', kind of thing/thinking. I experienced that to no end with NASA. It really gets in the way...old school outdated bullshit thinking. If we don't get some kind of update soon, it could be a real problem. Is there any other pending news on other pipelines/drugs?