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Flatlander 11 maart 2020 14:35

I was surprised that BCART did not bounce yesterday. Statistically, there is a 90% chance for a stock to rebound after the type of pasting that occurred on Monday. The technicals of BCART's price movement has become divorced from the fundamentals.

I listened to some EXAS conference calls yesterday and I'm a little concerned that the BCARTs ABC panel might be targeting a similar market as future product that EXAS is envisioning.. I think GHDX was accepting of this but EXAS management may be thinking it over.

FL

[verwijderd] 11 maart 2020 16:01

So what does that exactly mean?
Does they have better chances?

Tryck 11 maart 2020 16:13

www.politico.com/newsletters/prescrip...

BIPARTISAN BILL TO OVERHAUL LAB TESTS LANDS — A bipartisan, bicameral group unveiled legislation Thursday to overhaul how the FDA regulates laboratory-developed tests and in vitro diagnostics, David reports.

The VALID Act caps years of work by Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.), and comes as the Trump administration faces intense scrutiny over the CDC's botched rollout of its emergency coronavirus diagnostic.

“What we have learned over the years in successfully combating the spread of viruses, such as MERS, SARS and Ebola, is that time is of the essence,” DeGette said in a statement.

The coronavirus outbreak prompted last-minute changes to the 245-page bill, which will have companion legislation in the Senate sponsored by Michael Bennet (D-Colo.) and Richard Burr (R-N.C.).

"We took a step back to think about how to best give laboratories and developers flexibility they need to develop a test during public health emergencies," Bucshon said.

— What's in the bill: A major revamp of an FDA proposal for a precertification program — now deemed "technology certification." It also creates a breakthrough program, similar to the one for medical devices, to speed development and prioritize review of certain tests, as well as a user fee program to support test review.

The legislation requests that test makers establish and maintain an adverse event system, and report within five days if an in vitro clinical test poses an imminent threat to public health or is tied to events such as a patient death.

— But it could take a while to hit the floor. Major FDA legislation often moves during user fee reauthorizations, which is slated for 2022.

Tryck 11 maart 2020 16:16

degette.house.gov/media-center/press-...

In addition to permanently removing the pre-approval requirement for national emergencies going forward, the legislation – known as the Verifying Accurate, Leading-edge IVCT Development, or VALID, Act – would create a new product category for diagnostic and lab tests, putting their review and approval under the guise of the FDA going forward.

Flatlander 11 maart 2020 16:47

quote:
Nestel95 schreef op 11 maart 2020 16:01:
So what does that exactly mean?
Does they have better chances?

My impression is that BCART would still be subject to the device requirements. However, they would benefit from the fact that many of their competitors that are subject to the laboratory developed test (LDT) exemptions would be pulled under a more rigorous set of requirements under FDA. I've watched NGS companies like Guardant Health and Invitae roll out tests for sales with little in the way of any FDA interaction since they have been previously approved under CLIA program. I think the valid legislation might help level the field by subjecting LDTs to FDA oversight.

Again, it would be reasonable for BCART IR to comment on the impact (if any) of the proposed legislation.

FL

[verwijderd] 11 maart 2020 17:28

China shuts all 16 temporary coronavirus hospitals in Wuhan

nypost.com/2020/03/11/china-shuts-all...

Flatlander 11 maart 2020 17:30

The previous Idylla approval for the JnJ RSV panel came thru the 510(K) device pathway. I don't think BCART is directly influenced by the VALID act other than it makes the field fairer.

FL

MisterBlues 11 maart 2020 17:55

quote:
DeZwarteRidder schreef op 11 maart 2020 09:46:
[...]
Het probleem zit vooral in de verkoop- en algemene kosten.

Iedere nieuwe test levert heel veel aanloopkosten op.

Natuurlijk zijn de verkoop- en algemene kosten hoog. Ze hebben echter gezien de cashburn nog drie jaar. Komend jaar wordt echter beslissend.

In principe hoeft BCART niet veel geld meer in innovatie te stoppen dit jaar maar vooral wel in lobbyen: immers, een drietal geavanceerde oncologische testen, waaronder darm- en longkankertesten wachten op marktgoedkeuring.

Als dat gebeurt zal de groeiversnelling weer hoger komen en nemen relatief gezien de verkoop- en algemene kosten juist af.

Marktgoedkeuring van haar testen betekent ook dat gerenommeerde partners en institutionele beleggers weer bereid kunnen zijn om geld te gaan trekken. Typisch gegeven van biotech.

Vergeet niet dat de verkoop- en algemene kosten van de grote concollega's als Illumina en Fisher voor de eerste lijn oncologische testen veel hoger liggen.

Intussen moet ik wel toegeven dat het beursparcours van BCART mij uitermate begint te vermoeien. Dit jaar of begin 2021 moeten die marktgoedkeuringen binnen zijn. Ik wil stoppen met het BCART forum totdat de feiten duidelijk zijn - so I keep saying!!!Ik zie jou 10 maart 2021 en bedankt voor je bijdrage.

Flatlander 11 maart 2020 19:59

MB

Now that the troll lured you out, I'll add to your post. None of the partnership agreement terms have been disclosed. I think it is reasonable to assume that there are milestone payments. Regulatory approvals with the EU and/or the FDA are likely to bring significant payments under the collaborative revenue category.

FL

static1.squarespace.com/static/52cc70...

www.contractpharma.com/contents/view_...

Flatlander 11 maart 2020 20:19

I think I have a possible reason why JnJ has reduced its share count in BCART.

They have a highly promising small cell lung cancer drug based on a EGFR pathway (see link). The drug has received breakthrough designation from FDA based on early stage clinical testing. However, it is years behind the Astrazeneca drug for which BCART signed recent CDx agreements. I'm guessing that JnJ wanted BCART to sign a CDX agreement but BCART did not want to wait. Possibly, AZN had a better milestone payment package. The JNJ sell off timing correlates to the signing of the AZN CDX agreements.

FL
www.contractpharma.com/contents/view_...

www.astrazeneca.com/media-centre/pres...

DRTVR 11 maart 2020 21:50

Wie waagt om raad te geven om bij te kopen, of afwachten...., zou er van BC uit nog gecommuniceerd worden of laten ze ons in het ongewisse hoe het er nu aan toe gaat, wie weet meer?

Flatlander 11 maart 2020 21:51

If I'm right we can expect a new disclosure in the near future that J n J crossed the 5% notification criteria.

FL

FilipVanderAa 11 maart 2020 22:00

Flatlander, I have had biocartis shares ever since the IPO. I am at a - 65% loss today. But I'm not worrying. I'm going to take this opportunity to significantly increase my amount. I don't see any insiders selling their shares either. It's a very difficult market, but I'm convinced they've got a great product. And I'm convinced sales are about to pick up. Maybe wishful thinking, we'll see. Grtz

DRTVR 11 maart 2020 22:05

quote:
FilipVanderAa schreef op 11 maart 2020 22:00:
Flatlander, I have had biocartis shares ever since the IPO. I am at a - 65% loss today. But I'm not worrying. I'm going to take this opportunity to significantly increase my amount. I don't see any insiders selling their shares either. It's a very difficult market, but I'm convinced they've got a great product. And I'm convinced sales are about to pick up. Maybe wishful thinking, we'll see. Grtz

Bijkopen dus, denk dat de meesten op dit moment niet positief zitten.

Flatlander 12 maart 2020

If I'm right that JnJ has continued to sell because they object that a competitor signed an exclusive agreement with BCART (for EGFR and ctEGFR), then I think buying shares now is a good move. If this is the case, the time frame and presumably the milestone payments/schedule were likely the deciding factors. I would hope BCART would make decisions that would be in the long term interest of the company. It may be inevitable that short term fall out occurs because of these decisions. Anyone have any corroborating or conflicting information?

FL

[verwijderd] 12 maart 2020 08:31

zeker niet bijkopen , de beurs gaat de komende weken nog dalen verwacht ik met soms een opleving.

joe123 12 maart 2020 08:40

quote:
Flatlander schreef op 12 maart 2020:
If I'm right that JnJ has continued to sell because they object that a competitor signed an exclusive agreement with BCART (for EGFR and ctEGFR), then I think buying shares now is a good move. If this is the case, the time frame and presumably the milestone payments/schedule were likely the deciding factors. I would hope BCART would make decisions that would be in the long term interest of the company. It may be inevitable that short term fall out occurs because of these decisions. Anyone have any corroborating or conflicting information?

FL

Flatlander,ik ben mee met uw gedachtengang.Als dit allemaal klopt,waar blijft dan toch die communicatie naar de aandeelhouders.Men zou er een grote dienst mee bewijzen en zodoende de kleine beleggers hiermee terug vertouwen te geven?

DRTVR 12 maart 2020 09:51

quote:
jantje schreef op 12 maart 2020 08:31:
zeker niet bijkopen , de beurs gaat de komende weken nog dalen verwacht ik met soms een opleving.

Ga ik zeker doen met de cijfers van vandaag ...

[verwijderd] 12 maart 2020 10:00

Mijn gemiddelde aankoopprijs is opnieuw flink gedaald, nu zaaien en later oogsten.
Paniekverkopen zijn nooit goed, je koopt toch geen aandelen voor enkele weken, bekijk het op iets langere termijn en dan ziet alles er veel zonniger uit.

DRTVR 12 maart 2020 10:14

quote:
Laup 4 schreef op 12 maart 2020 10:00:
Mijn gemiddelde aankoopprijs is opnieuw flink gedaald, nu zaaien en later oogsten.
Paniekverkopen zijn nooit goed, je koopt toch geen aandelen voor enkele weken, bekijk het op iets langere termijn en dan ziet alles er veel zonniger uit.

Wie zal het zeggen wanneer het beste moment is om bij te kopen...

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