Ask The Analyst

Your questions answered by our experts


Ask the Analyst is a complimentary service that is included in your subscription.

Our expert analysts will assist you with questions about any of our news stories, analysis, or about any market or business issues that you face. We will conduct research and offer creative approaches to help answer your critical business questions.

How do I ask a question?

The service is accessible by clicking the Ask the Analyst button at the top of any article page and completing the form. Please take advantage of this valuable service and fill in the details of your request below. A Citeline analyst will respond to you directly by the next business day.

For requests where you would like to provide additional context or include a document as an attachment, contact the analyst team directly at askanalyst@sagientresearch.com.

If your request exceeds the maximum allowed hours, our analysts will discuss alternative options with you, which may include a referral to our Pharmaceutical Consulting team who can design a fee-based custom intelligence solution for you.

For technical assistance or training on use of Citeline News and Insights, contact Citeline Client Services at clientservices@citeline.com.

Ask the Analyst examples

  • I would like to get information on any precedence for companies applying for reexamination of their marketing authorisation application after a negative response from CHMP. Also, what options are there for applying for re-examination?
  • Are there FDA/ COJ rules for marketing and pricing a next generation drug by the same company? For example, if a company already has a drug in the market for an indication, and are developing the next generation drug for the same indication, are there rules around marketing and pricing to ensure the company doesn't make false claims to switch their patients to the next generation drug?
  • Are there mutual recognition agreements being considered for clinical site inspections?
  • Can the period of 7 years orphan exclusivity granted to a company for an orphan designated drug (e.g. indicated for the maintenance treatment of acromegaly patients, orphan designation: oral octreotide for the treatment of acromegaly) be extended for an expanded indication of the same orphan drug (e.g. for treatment of acromegaly in naive patients?
  • Can you advise if there are any specific license requirements (similar to the Spain sanitary license) for importing devices into Italy, France or Ireland? These would be CE marked Class I medical devices already marketed in other European Union countries.
  • Can you provide a list of countries that have a Mutual Recognition Agreement (MRA) with the FDA?
  • Could you give me a run down of major acquisitions in the dermocosmetics space over the past 3 years please?
  • Does Citeline have any analysis on the relative strengths/weaknesses of the 9 Humira biosim companies/approaches for RA? Have you seen any specific forecasts by company/therapy?
  • Can you provide me with a list of expedited approval pathways globally, for example FDA (breakthrough therapy, fast track, accelerated approval, priority review), EMA (adaptive licensing pathway, etc), Japanese PMDA, Health Canada, Swissmedic, Australian TGA.