Key Steps to FDA Approval for a Therapeutic Drug

Hello, this is Hall T. Martin with the Startup Funding Espresso -- your daily shot of startup funding and investing.

FDA approval is a lengthy and involved process with therapeutic drugs that startups must go through.

Here’s a list of the key steps to achieve FDA approval:

After basic research, the founder applies for an Investigational New Drug Application called an IND.

The founder takes the proposed therapeutic or drug through four phases of clinical trials.

Phase 1 is for safety testing.

Phase 2 is for effectiveness.

Phase 3 focuses on additional safety testing to determine side effects.

Phase 4 focuses on additional efficacy tests.

After testing comes the New Drug Application or NDA.

The FDA reviews the NDA, including the clinical data and research, to determine approval.

There are fast-track paths for drugs that treat serious medical conditions that have no current solution.

There is also a breakthrough therapy path for drugs that show substantial improvement over the current solution.

For investing in therapeutic startups, consider the FDA pathway for the drug and where it currently resides on that pathway.

Thank you for joining us for the Startup Funding Espresso where we help startups and investors connect for funding.

Let’s go startup something today.

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Check out our other podcasts here: https://investorconnect.org/
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In this episode of Investor Connect, Hall Martin speaks with Abdul Golden, an investor, operator, and mentor with a rich background in deep tech and entrepreneurship. Abdul shares the founding story of Shujaa Capital, his venture capital firm focused on democratizing tech investing for diverse and underrepresented founders, especially in undercapitalized regions like Africa. He highlights the undervalued opportunities in these markets and discusses the importance of financial impact and ethical practices in venture investing.

Abdul also touches on the emerging trends in minority-led startups and the evolving investment landscape in the US. He offers insights into how Africa’s young demographics and leapfrogging of legacy technology systems present unparalleled opportunities for economic growth and technological innovation.

This episode provides valuable perspectives on investing in emerging markets and the pivotal role of passionate, systematic approaches to making impactful investments.

Visit Shujaa Capital at www.shujaacapital.com or www.linkedin.com/company/shujaacapital

Reach out to at abdul@shujaacapital.com

Thank you for joining us for the Startup Funding Espresso where we help startups and investors connect for funding.

Let’s go startup something today.

_______________________________________________________

For more episodes from Investor Connect, please visit the site at: http://investorconnect.org

Check out our other podcasts here: https://investorconnect.org/
For Investors check out: https://tencapital.group/investor-landing/
For Startups check out: https://tencapital.group/company-landing/
For eGuides check out: https://tencapital.group/education/
For upcoming Events, check out https://tencapital.group/events/

For Feedback please contact info@tencapital.group

Please follow, share, and leave a review.

Music courtesy of Bensound.

Preparing for a Crowdfunding Raise

Hello, this is Hall T. Martin with the Startup Funding Espresso -- your daily shot of startup funding and investing.

Crowdfunding is a viable method for raising funding for a startup.

Here are some key considerations before pursuing a crowdfunding campaign:

Platform choice.

Look for the appropriate platform for your startup.

There are large platforms that are commonly used and many smaller ones that cater to niche audiences.

Look at the fees associated with the platform and their level of support for finding investors.

Most platforms provide for about 1% of the fundraising.

Marketing platforms.

Most crowdfunding campaigns require a network of 10,000 contacts or more to achieve initial success.

Look for marketing platforms that can generate more contacts at a cost-effective price.

It’s not unusual to find that social media and email marketing cost 20% or more of the fundraising.

Content creation.

Look for resources that can help generate the required content, including pitch decks, updates, digital assets, and social media posts.

Consider these steps before launching your crowdfunding campaign.

Thank you for joining us for the Startup Funding Espresso where we help startups and investors connect for funding.

Let’s go startup something today.

_________________________________________________________

For more episodes from Investor Connect, please visit the site at: http://investorconnect.org

Check out our other podcasts here: https://investorconnect.org/
For Investors check out: https://tencapital.group/investor-landing/
For Startups check out: https://tencapital.group/company-landing/
For eGuides check out: https://tencapital.group/education/
For upcoming Events, check out https://tencapital.group/events/

For Feedback please contact info@tencapital.group

Please follow, share, and leave a review.

Music courtesy of Bensound.