Софарма АД (SFA / SFARM)

[fortiss.]

Тръгвам...

[keizer]

И да споделите после интерсните моменти във форума! Аз съжалявам, че няма да мога да присъствам.
Приятно кафе с Г-н Донев.

[ivo0101]

Там сме!

[fortiss.]

Както усещам при г-н Донев столовете за нас трябва да са на два етажа!!!

[fortiss.]

Някой може ли да даде повече инфо къде и от колко часа ще се проведе ОСА и ако ще се събирате преди това как може и аз да се включа

9.3ч, на партера има барче - идвай!!!

[ivo0101]

Някой може ли да даде повече инфо къде и от колко часа ще се проведе ОСА и ако ще се събирате преди това как може и аз да се включа

[Black and white cat-foot]

И ?
реакция нулева .....

Тея цифри отдавна са отиграни от Чичовия.
Покер със свалени карти играете с него

И въпреки това, чичо ми прави пари всеки път

[petrg5s]

Sopharma registers 45% YoY growth of October stand-alone sales
Sopharma reported 45% YoY surge in Oct’23 unconsolidated sales, consisting of 42% YoY growth of exports and 53% YoY growth of domestic sales. 10-mo sales increased by 18% YoY due to 27% YoY growth of exports and 5% increase of domestic sales.

И ?
реакция нулева .....

Тея цифри отдавна са отиграни от Чичовия.
Покер със свалени карти играете с него

[fortiss.]

Sopharma registers 45% YoY growth of October stand-alone sales (POSITIVE)
	Sopharma reported 45% YoY surge in Oct’23 unconsolidated sales, consisting of 42% YoY growth of exports and 53% YoY growth of domestic sales. 10-mo sales increased by 18% YoY due to 27% YoY growth of exports and 5% increase of domestic sales. Source: Sopharma; FFBH

НАЙ

[tony1975]

Sopharma registers 45% YoY growth of October stand-alone sales (POSITIVE)
	Sopharma reported 45% YoY surge in Oct’23 unconsolidated sales, consisting of 42% YoY growth of exports and 53% YoY growth of domestic sales. 10-mo sales increased by 18% YoY due to 27% YoY growth of exports and 5% increase of domestic sales. Source: Sopharma; FFBH

[fortiss.]

Напомням за традиционното кафе при г-н Донев след ОС следващия петък!

[BSEtrader]

As I stated at the beginning of the call, 2023 has been a remarkable year for Achieve and the cytisinicline development program. In the near term, we have three key priorities where we will focus our efforts. First, finalized discussions with preferred strategic commercial organizations; second, complete preparations to finalize the NDA submission and third, define the regulatory pathway for cytisinicline label expansion in e-cigarette cessation. We maintain our confidence in cytisinicline's ability to change the face of public health and we appreciate your support as we work diligently to bring forward this important treatment.
...
And just any updates on the FDA inspection readiness on the - Sopharma front? And also any updates regarding preparations with regard to supply chain, getting the registration batch are all those processes on track?
John Bencich
Yes. Thanks for the question there. So I think the Sopharma and CMC attributes are going to continue to be focus as we move forward through NDA submission. As we've indicated historically, we've been working very closely with Sopharma and their readiness efforts including numerous mock FDA inspection audit. So that work will continue. As we progress and Sopharma continues to be confident that they can be ready for a future inspection. But it will continue to be a high area of focus for us as we proceed.

[BSEtrader]

Работят си хората

Over the last quarter as well as throughout the entire year, significant progress has been made in establishing the foundation for the first novel nicotine dependence treatment in almost two decades.
So far this year, with a small and efficient team of only 22 full-time employees, Achieve accomplished many significant milestones including the announcement of positive results from our second Phase 3 cytisinicline trial for smoking cessation and published results from our first Phase 3 trial in JAMA. Reported a statistically significant efficacy benefit in the Phase 2 ORCA-V1 trial, the first ever randomized controlled trial for e-cigarettes cessation.
We've completed three additional clinical studies of over 100 subjects required for NDA submission, made significant progress on the compilation of the NDA, held numerous interactions and conducted three formal meetings with the agency to prepare for filing and approval in the U.S., including most recently a pre-NDA discussion that occurred at the end of October and increased outreach and further discussions with potential commercial organizations on the cytisinicline U.S. and global marketing opportunity.
We believe pending FDA approval cytisinicline holds promise for providing a fresh start to the millions grappling with quitting smoking and vaping. There remain over 1 billion cigarette smokers around the globe. In the United States alone, over 28 million adult smoke combustible cigarettes and 11 million adult-based nicotine.
...
To that end, we have been focused on continuing the work needed to support an NDA filing targeted in the first half of 2024. We are pleased to share that we have completed all of the in-clinic treatment portion of three NDA-enabling clinical trials that have been running over the course of this year. Specifically, these trials have been run to evaluate QT interval prolongation, steady-state pharmacokinetics in smokers and pharmacokinetic parameters in subjects with renal impairment. We expect final study reports from these trials to be available in early 2024.
Additionally, last week, we held a pre-NDA meeting with the FDA. The FDA encourages this pre-submission engagement to solicit comments and clarification from the agency on the acceptability of key data including information that might become available for submission during NDA review. This initial discussion was constructive, an agreement was reached on many of the submission requirements. Dialogue with the FDA is ongoing and because of this, we aren't able to provide additional details at this time. We will be in a position to provide an overview once discussions are finalized.
The output of the pre-NDA discussion is critical to clarifying the final regulatory path of cytisinicline in the U.S. and will set the stage for how this product will progress through future market approvals around the globe. Additionally, these data points are important to furthering the discussions we are having with potential commercial organizations. Since ORCA-V1 and ORCA-3 have been released and ORCA-2 was published in JAMA. We have seen significant additional commercial interest in the cytisinicline program. As we have stated previously, we continue to believe the fifth asset in the hands of a larger organization will maximize the full commercial opportunity.
So what are we looking for exactly? Our ideal partner would have global capabilities with an established footprint and strong commercial capabilities and resources to maximize the global health impact that cytisinicline offers. Given the substantial U.S. market opportunity, strong U.S. sales and marketing capabilities are an important attribute that we are seeking in our selection process. We are pleased with the dialogue and engagement with potential commercialization partners and are focused on continuing to move this process forward expeditiously.

[petrg5s]

Да не объркат захарта и да стане солено това кафе

[tony1975]

Очакваме още интересни и добри новини преди това събитие, които да обсъдим при г-н Донев и които да ни подсладят кафето

Какво сме пропуснали?