Nabriva Therapeutics PLC (NBRVF)

[skitahoe]

Aren't there people among the regulators in European countries that the FDA would trust to make the inspection. Shouldn't European approval occur even if U.S. delays are still the case.

I'm relatively new to the stock, but not to biotechs, and the FDA has often frustrated me in the past. We've not yet been locked out of Europe, though it's apparently happening soon, this inspection could have been done over the past months had they chosen to do it.

I don't believe that the U.S. FDA is that much superior to those in many of the European nations. An inspection of manufacturing facilities should be something they could agree to do for one another, and they could even use Zoom, or a similar way to show the FDA what they're looking at, and let the FDA question what they're seeing.

Our insistence on doing it ourselves has cost many lives in Covid-19 where we insisted in developing our own tests, and messed it up badly, while tests used in other countries were available. Even today, many of the tests touted by the President are supposed to be very unreliable in both directions, people with the disease are told their negative, and people without it get false positives. We look more like a third world country than the world leader.

Gary

[Olde English 800]

Either way. Whether it in Spain or Ireland, or anywhere else international travel to and from the U.S. is on hold due to Covid 19. It will be an extended period before they will be physically going to inspect the manufacturer facility.

[Rapture2020]

Ugh. Spain. It's in Spain.

[Olde English 800]

I don't think it it bad news at all. I do however know that the manufacturing facility is in Ireland. Because of Covid-19, I think this might be delay for an extended time, because they have to FL to instruct it.

[ClayTrader]

* * $NBRV Video Chart 06-22-2020 * *

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

[peterus]

my 60s looking goodddd
soon $2 + with approval Xenleta for eu

[peterus]

should see news before 1 aug
approval Xenleta for europe
28 countries

[Jenslynild]

NBRV is down almost -25% premarket

[spotrader]

I suspect at least a moderate rise in sp
Because this is good news.

[Olde English 800]

No problem with the drug. The FDA is satisfied with it's safety and efficacy, but must inspect the manufacturer facility of the drug before it can be approved. Due to Covid19 travel restrictions, they were not able to fly to Ireland to inspect the facility. It is all there, in plain English. It might be next year before inspection. I doubt they thought about having a live video tour of the facility. That would have made too much sense.

[John-Knee]

BRIEF-Nabriva Therapeutics Receives Complete Response Letter From FDA On NDA For Contepo For Injection
2020-06-19 09:00:01 PM ET (Reuters)
   
   
June 19 (Reuters) - Nabriva Therapeutics PLC:

* NABRIVA THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FROM FDA ON NDA FOR CONTEPO™ (FOSFOMYCIN) FOR INJECTION

* FDA DID NOT REQUEST ANY NEW CLINICAL DATA & DID NOT RAISE ANY OTHER CONCERNS WITH REGARD TO SAFETY OR EFFICACY OF CONTEPO IN CRL

* CRL CITES OBSERVATIONS AT MANUFACTURING PARTNERS THAT COULDN'T BE RESOLVED DUE TO FDA'S INABILITY TO CONDUCT ONSITE INSPECTIONS

* CONTEPO BEEN GRANTED QUALIFIED INFECTIOUS DISEASE PRODUCT & FAST TRACK DESIGNATIONS BY FDA FOR TREATMENT OF SERIOUS INFECTIONS

* PLANS TO REQUEST TYPE A MEETING WITH FDA TO DISCUSS APPROPRIATE NEXT STEPS, FDA'S PLANS TO COMPLETE FOREIGN FACILITY INSPECTIONS Source text for Eikon: Further company coverage:

[zmster2033]

NEWS

https://investors.nabriva.com/news-releases/news-release-details/nabriva-therapeutics-receives-complete-response-letter-fda-nda-0

How do you all interpret this?

[peterus]

no think monday

[BusterDave]

Does anyone know if their manufacture passed inspec.?

[zmster2033]

You don't think they would have already released something today saying if it delayed?

[peterus]

think delayed like they thought.
should see a pr monday pre markt

[zmster2033]

Would there be news if it was delayed and/or rejected? Is it possible something comes out afterhours?

[peterus]

if we not see news before market close
you will see more panci selling

[Jess070283]

Loaded the panic! Thanks$$$$$

[peterus]

i smell danger
out for now
will get back in after good or bad news

[Jess070283]

I smell good news on the horizon. FDA approval!!!!!$$$$

[peterus]

if approval boommm

[StockEd_717]

FDA expects to rule on King of Prussia biopharm firm's new drug candidate ($NBRV):


https://www.bizjournals.com/philadelphia/news/2020/06/17/nabriva-fda-nda-urinary-tract-infection-kop.html

Positive news on the horizon...

[StockEd_717]

FDA expects to rule on King of Prussia biopharm firm's new drug candidate ($NBRV):


https://www.bizjournals.com/philadelphia/news/2020/06/17/nabriva-fda-nda-urinary-tract-infection-kop.html

Positive news on the horizon...

[StockEd_717]

FDA expects to rule on King of Prussia biopharm firm's new drug candidate ($NBRV):


https://www.bizjournals.com/philadelphia/news/2020/06/17/nabriva-fda-nda-urinary-tract-infection-kop.html

Positive news on the horizon...

[peterus]

big gamble here

[ClayTrader]

* * $NBRV Video Chart 06-16-2020 * *

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

[slicknick617]

I guess I should have used question marks and not exclamation points as I was repeating, as a question, what someone had put in an earlier post.

[John-Knee]

Nabriva Therapeutics Sees Unusually High Options Volume (NASDAQ:NBRV)
Posted by Adam Masters on Jun 16th, 2020 [Dakota Financial News]

Nabriva Therapeutics – (NASDAQ:NBRV) was the target of unusually large options trading activity on Monday. Stock traders bought 20,345 call options on the company. This represents an increase of 1,910% compared to the typical daily volume of 1,012 call options.

[John-Knee]

Pushing above 1.00 despite all the selling pressure.

[zmster2033]

Time to see if we can hold $1.00!

[DorseyE]

DOW futures up!!!
Maybe a good day coming.....

[Rapture2020]

LOL. YOU ARE A TOTAL MESS. EARNINGS FRIDAY? SMH.

[slicknick617]

NBRV Covid-19 play !!!! If so you may want to spread the word to everyone that you know and let them know earnings come out on Friday.

[ClayTrader]

* * $NBRV Video Chart 06-15-2020 * *

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

[Jess070283]

Let’s bust a $1 and open the gates!$$$$

[John-Knee]

Sellers are still holding the price from running up with several walls. Eventually, it will dry up and upward she will go. The overall trend is still bullish.

[SkeBallLarry]

( NBRV ) ~ Good Movement 'n Volume .. !!

[teevo]

what do you mean sir

[Rapture2020]

Try to keep up.

[teevo]

"CRL issued April 30, 2019. New PDUFA date June 19, 2020. Company noted May 29, 2020 that there is a substantial likelihood that the FDA will not be able to complete its review due to COVID-19."

https://www.biopharmcatalyst.com/calendars/pdufa-calendar#NBRV

Got this from this website. What does this mean?

[skitahoe]

It's my belief that when a company drops the O/S to anything like 14 million shares it won't be 3 years before it's back to 50 to 100 million, and that means the original shareholders equity is reduced to a tiny fraction of the total in the company.

A R/S that brought the share count to 70 million, i.e. 1 for 2, would be more reasonable, and if it did grow to near 150 million, at least the original shareholders would have nearly 50% of the equity.

I intend to vote no, and hope others will join me.

Gary

[John-Knee]

I am not in favor of a R/S either. It normally doesn’t bold well.... but Nabriva does have hard assets to support the price retreat post R/S. I am assuming they are going for 1:10 ratio to keep the OS down to approx 14 million and give enough room when price does go down post R/S.

Could the recent volume activity was to acquire shares for the purpose of R/S voting?

Any other insight from others are greatly appreciated.

[skitahoe]

I've only recently invested here at the suggestion of someone who's advice I respect. I'm not thrilled by the perspective of a vote authorizing a reverse split so far in advance of the extended deadline imposed by the Nasdaq. I wanted to see the thought of others on this item.

My thoughts are twofold, for one, only a 2 for 3, or 1 for 2 would be all that's necessary to achieve over a $1 based on current prices, why vote on a 1 for 10. The other is it's much earlier than necessary, and on more than one occasion I've seen the reverse split done well before it was needed, and in fact it may not have been needed at all.

I welcome others thoughts.

Gary

[knrorrel]

Tuesday was loaded very well and you could see how fast it can go up when a few buyers come in and I think yesterday was day 1 of our long big one

super CHART, good SS, FDA admission should come when many speculate that are still on the edge, great Pipeline, very good field of activity, awesome catalysts and a lot of imagination for a long climb high into the double-digit range....imho


https://www.stockscores.com/charts/charts/?ticker=Nbrv

[Menace trader]

Shorts be cover. This pup is about to explode. Lots of interesting things happening w Nabriva

[BiotechValues]

$NBRV apparently an unknown COVID-19 play

See pop-up on site

https://www.nabriva.com/

[John-Knee]

Inching our way above a dollar. The recent offering brought several well known Institutional investors.

[ClayTrader]

* * $NBRV Video Chart 06-09-2020 * *

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

[Jess070283]

Yep can’t hold it down forever! Unleash the beast!!!$$$