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Expert Interview

Slingshot members are talking to an expert! The topic is:

Where does Antares Pharma's (ATRS) QuickShot® Testosterone (QST-15-005) fit into the Low-T market?

Ticker(s): ATRS, ENDP, LPCN, ABBV, LLY

Who's the expert?

Name: Dr Culley Carson - MD

Institution: UNC

Bio:

  • Rhodes Distinguished Professor in the UNC Department of Urology. 
  • Specializes in the area of Men's Health, including the treatment of Peyronie's Disease, Erectile Dysfunction. and penile prostheses. 
  • Has published more than two hundred peer review publications and edited several textbooks. Dr. Carson currently serves in a number of national and international professional capacities, including as President of the American Society for Men's Health and Congress President for the International Society of Men’s Health.

Interview Questions
Q1.

Please describe your background treating Low-T. How many patients you currently have on testosterone replacement therapy? Please describe the breakdown between the topical products and the injectables.

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Q2.

How often do patients on a low-t therapy come in for follow-up visits?

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Q3.

For the patients that are using injections today, are they having someone outside of your office administered the DIM shot to them or is an office visit required?

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Q4.

Regarding the data presented in November at the Sexual Medicine Society of North America (SMSNA) meeting, at a high level was are your general impressions of the data?

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Q5.

Looking at their data, there was ~5 percentage PSA elevation, 6% polycythemia and one patient discontinued for prostatitis and then a several other side effects such as injection site reactions, bruising, erythema is just redness, pruritus.

  • Are what you would expect from just regular testosterone versus this product in specific?
  • Is anything within that side effect profile particularly concerning to you?

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Q6.

From a pain perspective, I think either 4 patients or 7 patients out of around 1500 injections presented with pain. What is your impression of this data?

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Q7.

Once patients are on this treatment, do they have a steady state dosing or more of a "rollercoaster" effect? Is there a potential lack of titration advantage here? How does that factor into the potential usage product vs. existing treatment options?

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Q8.

What's your opinion on the likelihood that QuickShot would make it through the FDA given some of the issues some of the oral testosterone products have had? How similar or different do you think the review of this would be to some of the more problematic recent examples?

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Q9.

From a cardio tox perspective, how concerned do you think the FDA would be about this as a 505b2 application?

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Q10.

Let's say this product was available tomorrow. Given what you know about the profile, how would you use this product, vis-a-vis the your current patients on injectables, as well as gels? Is there a reason why you would potentially switch a patient to this product and would you be inclined to use it for new patients?

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Q11.

Do you see reimbursement being an issue with this treatment?

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Q12.

Do you have any other sort of concerns about this product?

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Q13.

On a scale of 1 to 10, 10 being really really excited and 1 being not so, where would you put your level of excitement for this?

Added By: c_admin

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