Post by mnholdem on Oct 20, 2016 12:29:42 GMT -5
Have you noticed how Matt listed three ways post-marketing trial data can affect the label? That's because the data presented in each of the three bullet points will affect the Afrezza label in its own unique way:
Approximately the 3rd week of September, I sent an inquiry to MannKind Corporation and asked how they were progressing in regard to CEO Matt Pfeffer's comments and slide presentation at the Rodman & Renshaw Investors Conference on September 12th for their planned FDA Label Change submission by late September.
The reply I received from MannKind's Investor Relations Department was that the company was "parsing" the data for multiple submissions to the FDA related to the Afrezza label. It is their belief that a label change related to a drug's efficacy would typically take the longest to get reviewed by the FDA.
If you look at the three bullet points on the slide presentation (above), two stand out which could result in label changes in 30 days:
- Post-marketing PD/PK data, which affects the graphs & charts used in Afrezza's current label, and;
- Dose and titration information, which will affect the label's instructions on how to use Afrezza to obtain optimal results.
Efficacy data, which can be used by MannKind to address how the post-marketing trial data relates to a reduction of hypoglycemic events, could take 6 months for the FDA to complete its review.
