Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
Mr 9787: You are correct in stating that Mannkind has not reported detailed Phase III results yet, mostly because the major Phase III trials won't be over and the data in till the end of this year.
However, your implication that my statement that "Mannkind found no evidence of any drop in lung function whatsoever in their clinical trials" is not well-founded is not correct. Exubera was found to cause reduced lung function within a few WEEKS. Although Mannkind did not yet release Phase III data, they did release lots of Phase II data, with studies 3 months and 6 months long. In none of those studies was there any evidence of reduced lung function, which was specifically tested for using all the standard tests. I think that is ample evidence to show that it doesn't have Exubera's problems in that regard.
I see no reason why the FDA would arbitrarily recommend pulmonary tests for Technosphere Insulin if it shows no problems in that regard. However, they will probably (and sensibly) advise against asthma patients, etc., using it until tests are done in that subset of the population.
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Mr 9787:
Jun 13 11:34 am
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All Comments by Ahithophel Weissberger »Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
You are correct in stating that Mannkind has not reported detailed Phase III results yet, mostly because the major Phase III trials won't be over and the data in till the end of this year.
However, your implication that my statement that "Mannkind found no evidence of any drop in lung function whatsoever in their clinical trials" is not well-founded is not correct. Exubera was found to cause reduced lung function within a few WEEKS. Although Mannkind did not yet release Phase III data, they did release lots of Phase II data, with studies 3 months and 6 months long. In none of those studies was there any evidence of reduced lung function, which was specifically tested for using all the standard tests. I think that is ample evidence to show that it doesn't have Exubera's problems in that regard.
I see no reason why the FDA would arbitrarily recommend pulmonary tests for Technosphere Insulin if it shows no problems in that regard. However, they will probably (and sensibly) advise against asthma patients, etc., using it until tests are done in that subset of the population.