Aandeel Biocartis BRU:BCART.BL, BE0974281132

quote:

Flatlander schreef op 9 januari 2020 18:32:

BL

I agree that the differences in our numbers may very well be the source of the information on consoles and cartridges. I look at it as a quick and dirty confirmation that the system sales are resulting in increased usage of the platform. I may have pulled the numbers from an unaudited source.

FL

quote:

Flatlander schreef op 9 januari 2020 19:05:

I like tracking on a half year basis since we do not have that many data points. Either way the relative direction is the important point. This number could increase by a factor of 10 or more if the RUO designation can be replaced by clinical diagnostic approval in several world markets.

I have put up several posts that suggest that the problems in the U.S. may be more of a problem with the regulatory framework than a problem with Idylla. Unfortunately the FDA is trying to apply the medical device approval process rather than a more appropriate genomic testing standard that the Obama administration proposed over a decade ago. The FDA 510K process generally emphasizes precedents and requires the manufacturer to compare results to existing equipment already on the market. In the case of Idylla this is tough since there are no similar IVD devices to compare its results to. Former commissioner Gotleib had changing the IVD approval process as a priority but for whatever reason, he decided to resign instead. FDA has internal guidance documents (see link below) but not comprehensive legislation from Congress. This is the reason I keep mentioning that BCART may have to be assertive to counter the lack of appropriate guidance from Congress.

Here is an overview of the FDA process that BCART has to seek approval under.

www.fda.gov/medical-devices/ivd-regul...

Note that Idylla is likely bumping up against the De Novo classification (meaning no adequate precedent system exists for comparison). For this reason FDA might likely be requiring validation studies. It would seem that these are temporary hurdles, but none the less they hinder more rapid expansion of sales.

FL

quote:

Flatlander schreef op 9 januari 2020 19:05:

I like tracking on a half year basis since we do not have that many data points. Either way the relative direction is the important point. This number could increase by a factor of 10 or more if the RUO designation can be replaced by clinical diagnostic approval in several world markets.

I have put up several posts that suggest that the problems in the U.S. may be more of a problem with the regulatory framework than a problem with Idylla. Unfortunately the FDA is trying to apply the medical device approval process rather than a more appropriate genomic testing standard that the Obama administration proposed over a decade ago. The FDA 510K process generally emphasizes precedents and requires the manufacturer to compare results to existing equipment already on the market. In the case of Idylla this is tough since there are no similar IVD devices to compare its results to. Former commissioner Gotleib had changing the IVD approval process as a priority but for whatever reason, he decided to resign instead. FDA has internal guidance documents (see link below) but not comprehensive legislation from Congress. This is the reason I keep mentioning that BCART may have to be assertive to counter the lack of appropriate guidance from Congress.

Here is an overview of the FDA process that BCART has to seek approval under.

www.fda.gov/medical-devices/ivd-regul...

Note that Idylla is likely bumping up against the De Novo classification (meaning no adequate precedent system exists for comparison). For this reason FDA might likely be requiring validation studies. It would seem that these are temporary hurdles, but none the less they hinder more rapid expansion of sales.

FL

quote:

Reply schreef op 9 januari 2020 21:16:

Is het verder nog iemand opgevallen dat er in de eindveiling nog even voor zo'n 1 miljoen EUR aan stukken werd verhandeld?

Dat was echt een aardig pakket hoor wat daar snel nog even over de toonbank heenging!

quote:

Flatlander schreef op 10 januari 2020 17:27:

Reply

The fact that the FDA approval process is the same as surgical instruments and the like rather that the specific MDx regulations that were proposed a decade ago is a testament to political dysfunction. You can probably sense my frustration with the issue. I'm sure FDA is also frustrated. That is why I keep stressing the fact that others have resorted to lawsuits when they felt they were at an impasse.

Funny thing is that our politicians from both parties grandstand about why the costs of health care in the U.S. are about twice that of other developed markets. Passing common sense legislation would go along ways toward bringing life improving products to the consumer.

Regards FL

quote:

Flatlander schreef op 10 januari 2020 15:44:

Reply

Wish I spoke Dutch! The tone sounded positive.

I have a couple random thoughts.

I wish I knew the specific reasoning of Sycamore, JnJ, RM and DeBioPharm reducing or eliminating their stakes in BCART. DeBioPharm is a major investor in Immunexpress and much of their involvement with BCART seems to date back to the earliest stages of the Septicyte collaboration. RM appears to have sold in conjunction with his resignation from the Board. There appears to be a shift toward a more American based shareholder base. Invesco (formerly Oppenheimer), DFA have excellent reputations in small cap investments. I'm not overly concerned, but just like some sense of the motivation factors of fellow shareholders. Did the sellers take the H1 2019 numbers presented in September as more than a hiccup that it now appears to be?

Trading action in BCART looks good today. I was hoping to see such follow thru confirmation after the short term profit taking at the end of yesterdays session..

Have a Good Weekend.
FL

quote:

Flatlander schreef op 9 januari 2020 23:41:

BL
I agree wholeheartedly that BCART is priced relatively cheaply for the current growth and especially for the potential future growth. My point was that the U.S. MDx market was becoming decidedly frothy. EXAS at a $15B market cap seems very expensive to me. Since so much of their potential worldwide growth in OncoTypeDx is dependent on Idylla, I'd much rather be in BCART since it would benefit from the launch of the same content throughout the world. Furthermore, I like platform companies. As long as partners keep stepping up to launch on Idylla they have a lot of shots on goal to accelerate from what is already very enviable growth.

Much of the US market is invested passively thru ETFs. I think they are damping the kind of volatility that would have shaken weaker hands out of the market. This is likely leading to overvaluation in some areas of the U.S markets. Earnings in the S&P were flat in 2019 yet the S&P Index was up 29%. I don't think you can pull that rabbit out of the hat too many years in a row. I'd much rather be investing in BCART despite the fact that it is far below the radar of most worldwide funds. The relative value difference convinced me to add to my position on Wed.

Regards FL