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Flatlander 10 september 2019 16:32

To date, the only FDA approvals in the US have come largely through the efforts of JnJ. The 2017 console, and the RSV cartridge approval were largely JnJs doing. The RSV cartridge was apparently rendered obsolete by competing devices and Biocartis decided to exit the infectious disease market.. I took the 2018 announcement that Biocartis was opening a facility in the JnJ space in Raratan NJ and acquiring 10 JnJ staff as a sign that they would tap JnJ strengths to expedite winning regulatory approvals. This has not been evident. My concern now is that JnJ may looking to acquire BCART on the cheap. If BCART continues on this trajectory the they may need to raise cash again in late 2020 or early 2021. This will be difficult unless the outlook changes. As I mentioned previously, there are many catalysts that can change the trajectory for the better, but the execution needs to improve.

There is still a lot of time. Rather than emphasizing the buildup of a US sales force (an expensive proposition), I think BCART needs to emphasize regulatory approvals that will make Idylla eligible for insurance reimbursement. With regulatory approvals, their partners will help sell and they can avoid the advertisement restrictions that are currently constraining marketing in the US.

FL

Flatlander 10 september 2019 16:48

Don't want to come across too negative.but history is littered with companies that brought new technology to market only to have someone else succeed in making it commercially successful (think about the commodore PC). The pathology journals I have read indicate strong support for first line use of Idylla but the business execution does not appear to be capitalizing on this potential. As I've indicated from my experience with GHDX, it can take a while before a critical mass of support is developed that allows commercial traction possible. The partnerships and the technical seminar presentations (especially user testimonials) are critical in developing this support.

FL

ronald64 11 september 2019 07:00

quote:
makyjo schreef op 10 september 2019 16:24:
Ideaal om NU bij te kopen.
Alleen voor de durvers!!
Want is zeker een andere verhaal dan Thrombogenics. (Oxurion)

Biocartis berichtte vorige week woensdag over een halvering van de oorspronkelijke groeiprognoses. Vorige week woensdag noteerde het aandeel vlak voor de domper nog € 10,28. De groeibijstelling leidde donderdag tot een vrije val naar € 6,98. Zojuist werd € 6,50 op het koersenbord gesignaleerd. De koershistorie van Biocartis toont in 2016 een bodemproces tussen € 6,69 en € 6,59. De relatieve sterkte index raakte vorige week het meest oversold in relatie tot voorgaande oververkochte waarderingen. Traders die zich afvragen wat te doen in deze overwegend afwachtende markt weten dat de beste koopmomenten zich voordoen als het spreekwoordelijke bloed door de straat loopt.

joe123 11 september 2019 09:48

[quote alias=DeZwarteRidder id=11820851 date=201909101526]
[...]
Ja, J&J en Amgen gaan graag de concurrentie een handje helpen..........!!!
[/qu
J&J is grootaandeelhouder,en met Amgen is een deal afgesloten.
Toch niet onrealistisch dan?

Flatlander 12 september 2019 00:56

Apparently Fisher has not taken the Idylla Console systems off of its exchange, yet.

FL

www.fishersci.com/us/en/catalog/searc...

Look0406 13 september 2019 11:51

quote:
ronald64 schreef op 11 september 2019 07:00:
[...]

Biocartis berichtte vorige week woensdag over een halvering van de oorspronkelijke groeiprognoses. Vorige week woensdag noteerde het aandeel vlak voor de domper nog € 10,28. De groeibijstelling leidde donderdag tot een vrije val naar € 6,98. Zojuist werd € 6,50 op het koersenbord gesignaleerd. De koershistorie van Biocartis toont in 2016 een bodemproces tussen € 6,69 en € 6,59. De relatieve sterkte index raakte vorige week het meest oversold in relatie tot voorgaande oververkochte waarderingen. Traders die zich afvragen wat te doen in deze overwegend afwachtende markt weten dat de beste koopmomenten zich voordoen als het spreekwoordelijke bloed door de straat loopt.

Aldus Loef.
Inderdaad mooi koopmoment, iedereen die er uit wilde is eruit.

FDJ30 13 september 2019 13:39

quote:
Look0406 schreef op 13 september 2019 11:51:
[...]
Aldus Loef.
Inderdaad mooi koopmoment, iedereen die er uit wilde is eruit.

Het begint nu wel een zielig afglijden te worden van de koers, waar stopt het...

Look0406 13 september 2019 13:54

quote:
FDJ30 schreef op 13 september 2019 13:39:
[...]

Het begint nu wel een zielig afglijden te worden van de koers, waar stopt het...

Ong. 6,5 euro

Look0406 13 september 2019 14:25

Nu dubbele bodem rond 6,5
2e bodem lager volume
Positieve divergentie

Flatlander 17 september 2019 07:09

www.fishersci.com/us/en/catalog/searc...

The situation with Fisher in the US has become pretty transparent. They continue to market the consoles on the Fisher platform but not the cartridges. The console has received a determination that it is exempted from FDA 510K approval process. But the assay cartridges are approved in the US for research use only RUO designation..

www.globenewswire.com/news-release/20...

Trading of Biocartis on the Schwab global platform is suspended on a regulatory violation (SEC Regulation S), This regulation limits the advertising statements that can be made about a product until it has secured approvals. Putting 2+2 together, it is apparent that it is likely that Fisher overstepped the advertising limitation that can be made under the RUO designation. Hence, they can no longer sell the cartridges on the Fisher exchange site.

I believe the cartridges came off of the exchange in early July explaining the big US sales miss. I think BCART had no other choice but to internalize the sales so they can strictly control the promotional materials and the sales pitch. This can be corrected with FDA 510K approval of the assay cartridges.

The good news is that if a product is truly an advancement, it can be very successful even if it stumbles in the U.S. Possibly due to no fault of its own. I've invested in Novartis for a long time. They brought a diabetes drug called Galvus to the FDA for approval and it got rejected on concerns over early animal testing rashes during the preclinical trials. This happened despite one of the largest Phase III studies ever conducted at the time bearing out the efficacy and the lack of this drug side effect. Galvus went on to become a blockbuster with approvals throughout the world but it never came to market in the US. NVS saw the writing on the wall and withdrew the FDA approval application and never refiled despite the US market being the largest diabetes market in the world.. This opened the door for Merk's competing drug Januvia. My point is that regulatory powers are often applied in ways that are designed to benefit domestic competitors.. Unfortunately it happens throughout the world. However, if the product is a true advancement, it can still do great even with trade barriers that might create temporary stumbles. It is critical to recognize the nature of the impediments and to determine how to best allocate resources given the impediments. The right partners can also make all the difference in gaining regulatory approvals.

FL

FDJ30 19 september 2019 11:02

en.....weg dubbele bodem, waar gaat dat stoppen..
Ik koop nog bij op 6.10 en lager...

FDJ30 19 september 2019 11:22

PS kan het zijn dat ze de koers in elkaar trappen aangaande een speler die aast op een overname?

CGCDLR 20 september 2019 16:40

Zo, dit hebben we ook alweer gehad Q3 voorbij,koers gehalveerd . Zaterdag 28/09 staat Biocartis op het Biotechpaviljoen, tijdens de dag van de tips (?). Georganiseerd door deVFB.Benieuwd wat hij nu uit z'n nek zal staan lullen,of zend hij z'n kat.

[verwijderd] 23 september 2019 08:55

kwaliteit komt altijd bovendrijven, we gaan terug naar aanvaardbare waarden terugkeren de komende weken...

Flatlander 24 september 2019 19:09

Tomorrow's meeting and the turmoil since the Sept 5 earnings announcement will result in some shakeup in the shareholder base. I expect that some consolidation is occurring as some smaller holders are getting shaken out. The shareholder base is currently widely disseminated such that it would be difficult to acquire BCART without wide shareholder support. Consolidation will reduce the number of holders, such that an acquisition might be easier in the future. I'm not saying anything is imminent, only that the dynamics are likely to be changing.

FL

Flatlander 24 september 2019 21:06

GHDX Conf Call discussion of Biocartis from 13:45 - 17:00.

edge.media-server.com/mmc/p/c434qn2q

Don't think any of this is new. However, GHDX conference calls express a lot more optimistic tone than the BCART calls.

FL

Dominiek007 25 september 2019 11:29

Wat gebeurt er vandaag?

FilipVanderAa 25 september 2019 12:31

This is starting to hurt. Did I miss something?

DeZwarteRidder 25 september 2019 14:13

quote:
FilipVanderAa schreef op 25 september 2019 12:31:
This is starting to hurt. Did I miss something?

Ja, een hoop geld....!!!

Dat komt er van als je in (Belgische) sprookjes gelooft.

DeZwarteRidder 25 september 2019 14:15

Als de koers zo laag blijft ziet het er slecht voor Biocartis, want dan kunnen ze hun converteerbare lening niet aflossen en volgt er waarschijnlijk een gedwongen equity-swap (of erger).

Denk aan Nyrstar......

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