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the European Atherosclerosis Society congress 2021
https://eascongress2021.com/programme/educational-cme-accredited-programme/
PD, probably not "they have", but "they will".
PREPARE-IT update: Really!?
How will they recruit 1,300 more participants in a month?
https://clinicaltrials.gov/ct2/show/NCT04460651?term=icosapent&recrs=ab&draw=2&rank=11
Sleven, thank you!
What is the source of info?
Oral arguments next week Wednesday?
NS, google translate is so bad.
It is expected that the original company will file a defense before the end of May, but according to the past experience, there is not much chance of reversing the case in the third trial; what is more worthy of attention is that the Indian pharmaceutical company, which also obtained the drug certificate with the company's customer before the end of last year, has not yet marketed its products due to the supply of raw materials and the epidemic, which also gives the customer a relatively exclusive advantage.
Translated with www.DeepL.com/Translator (free version)
CCSB update:
https://translate.google.com/translate?hl=en&sl=zh-TW&u=https://www.moneydj.com/kmdj/news/newsviewer.aspx%3Fa%3D2d745b38-4aee-45c3-9a69-57984289b99c&prev=search&pto=aue
The product mix is ??getting better. The gross profit margin and profit margin of the raw material pharmaceutical company CCSB in the first quarter simultaneously set a new high since 2010, with a single-quarter after-tax profit of 1.27 yuan per share; the company said that the second quarter received a strong order. In the first quarter of Asia, the part of the delayed shipment due to air freight in April was recognized in the first week of May. Because of the optimistic about the market development of fish oil raw materials, the board of directors passed a new wave of expansion plans, and the annual output is expected to be 300 tons. The sexual manufacturing process will be completed early next year, and the visibility of orders is now available until next year.
CCSB's first quarter gross profit margin was 50.6% and profit margin was 26%, both hitting a new high in 2010, mainly due to the decrease in the proportion of chemical synthesis products with lower gross profit margin, and the cost reduction benefits of fish oil raw materials due to the expansion of the manufacturing process , Exceeding expectations, all drove gross profit margins higher.
Although the company’s April revenue fell below the 100 million yuan mark, it was mainly due to a batch of goods that were originally planned to be shipped at the end of the month with a large amount. Due to the deferred air freight, they were not recognized until the first week of May. In terms of receiving orders, the second quarter is still better than the first quarter, but the company emphasizes that the current air transportation capacity is still the key to the delivery recognition time, but the latest internal confirmation to the airlines that the transportation capacity of the United States should not be affected.
CCSB also pointed out that the fish oil customer won the second trial in the patent battle with the original manufacturer. It is expected that the original manufacturer will submit a defense before the end of May. However, based on past experience, the third The company's customers have also obtained drug certification in Indian preparation plants. Due to the supply of raw materials and the epidemic, the products have not yet been put on the market, which also allows customers to obtain a relatively exclusive advantage.
CCSB also said that the current visibility of fish oil raw materials will be available until next year, and the price will be roughly confirmed. The next wave of continuous fish oil production expansion will reach an annual production capacity of 300 tons. It is expected to be confirmed early next year. Send it to FDA and client for certification.
The company explained that if the FDA determines that the new process is a minor change, it can be integrated into mass production one month after the validation approval. If it is determined to be a major change, the time from validation approval to mass production may be extended to 9 months.
Supply limitation will remain forever unless synthetic EPA becomes available. As long as Amarin secures supply, exclusivity is not a big issue.
sts, V's market is in infant stage now. Market growth takes time and will be slow, but in 5-10 years, market size will be huge (potentially 2 million scripts/week in only US)
Potential peak (IMO): 2 million scripts/week in only US
NS, it is the current supply capacity of CCSB. At the end of this year, their capacity will be 300 mt (about 50,000 scripts/week).
Rob, thank you for the info! With 100 mt supply from CCSB, generics (Hikma and Dr. Reddy's) can get approximately 16,000 scripts/week.
I hope EMA update their recommendation from "1g" to "4g" in the near future.
Great question from Viet Le
Question to all:
— Viet Le DMSc PA-C FACC FAHA HF-Cert (@VietHeartPA) May 16, 2021
Given risk of AF in EPA/DHA formulations without the MACE benefits as seen in EPA-only, how strongly will you recommend pts NOT to take off-the-shelf EPA/DHA supplements?#ACC21 #AF #OM3 #STRENGTH #REDUCEIT
zmanindc,
Again, retrospective study (eg, data mining) wound not change the minds of top scientists like Dr. Nissen, unfortunately. The trial in Japan is a real world trial. Its positive data (despite low dose) will strongly support RIT and Jellis.
We don't rely on retrospective study (eg, data mining), but prospective study (eg, RCT).
zmanindc, ongoing study in Japan +/- MITIGATE trial may explain it.
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014051
Interesting comment (2 years old)
https://www.sciencedirect.com/science/article/pii/S2213177919302641?via%3Dihub
Measurement of EPA should be a standard of care in the future.
https://www.jacc.org/doi/full/10.1016/j.jchf.2019.03.008
JIMO, if measurement of absolute EPA or EPA:AA ratio becomes standard of care, V's sale will increase significantly.
The success of zetia is/was because measurement of LDL is a standard of care and Merck's been a good marketer.
zmanindc, If the results are positive, Amarin will need a larger study for sNDA. Current V's alzheimer trial is too small (only n=150) to obtain sNDA. BIIB's Aducanumab study has n=1,647.
yudilks, I don't think AMRN's SP will move significantly for the next couple of years without success of COVID trials, but I believe AMRN will be successful in 5-10 years regardless of COVID trials. I'm not optimistic for short term (for the next few years), but long term.
ralphey, if the results of COVID trials are positive (excellent), infringement is not the issue anymore. There is not enough supply to meet its demand in the world.
PD,
PD,
That's true.
PD, they don't lose the integrity of the trial even if they announce its topline results and give the data to FDA before publishing it. I don't know how they lose it unless there is a scientific misconduct. Otherwise, its integrity is determined when they designed the trial. In addition, FDA is more thorough than peer-review journals (eg, NEJM).
Anyway, whether they announce topline results or not, we need to wait the results until June or July.
PD, investigators have changed their protocol a couple of times, and N is now 2,200 for both prepare-it 1 and 2. (see
)I don’t think so. We have PREPARE-IT 1 (prevention) and PREPARE-IT 2 (out patient treatment). Both with 4 g EPA (not DHA). N=2200 both.
— Pablo Corral MD (@drpablocorral) April 17, 2021
north, I think it will be like R-I trial topline results were announced on 9/23/2018 and further results embargoed for release on 11/18/2018. If COVID trials results are significant, ethically, they should announce the results (at least topline results) ASAP. No mention anything about announcement in tweet.
NS, from my understanding, it has not been embargoed yet. Colchicine study has.
north, IMO, it depends how significant the result will be. If the results are significant (excellent), they will announce them ASAP. If not, probably embargoed for publication.
Kiwi,
PREPARE-IT 1 y 2 están reclutando aún. COLCOVID finalizado y embargado por publicación cercana
— Fernando Botto, MD, MSc (@ferbotto) April 18, 2021
Health Net barely mentioned about prior authorization which is the key fact of infringement.
Kiwi, re: prepare-it 1, they were still recruiting participants as of 4/18, and n =2,200, not 2,000.