The Arikace clinical trials were never about the efficacy of the antibiotic.
The amikacin payload within Arikace is already approved by the FDA and EMA.
There is no question it kills Mycobacteria (NTM and TB) and Gram-negative bacteria (Pseudomonas, Klebsiella pneumoniae etc) which are resistant to the vast majority of antibiotics.
The Arikace clinical trials asked just three questions -
1. Does Arikace deliver an effective concentration of amikacin to a pulmonary Gram-negative or Mycobacterial infection?
2. Does delivery via inhalation prevent the serious adverse effects which currently restrict the use of amikacin to infections resistant to first-line antibiotics?
3. Does the liposome carrier cause adverse effects?
Arikace has now passed all three tests.
Proof that Arikace safely delivers an effective concentration of amikacin to Non-Tuberculosis Mycobacteria in the lungs is also proof that it will safely deliver an effective concentration of amikacin to Mycobacterium Tuberculosis in the lungs.
Amikacin injection is currently a top-ranked therapy for Multi-drug-resistant Tuberculosis. Worldwide an estimated 630,000 currently develop MDR-TB each year.
The Chinese regulatory body recently pushed through expedited approval of Bedaquiline as an additional therapy for the estimated 120,000 Chinese who currently develop MDR-TB each year.
Arikace is far safer than Bedaquiline. The recommended 24-week course of Bedaquiline would cost around twice as much as the course of Arikace which converted 25% of trial participants suffering from drug-resistant NTM to culture-negative in just 12 weeks.
To my knowledge no analyst has ever mentioned the potential use of Arikace as a therapy for MDR-TB.
Either I'm talking utter drivel here .....
Or these analysts don't want retail investors to know that INSM is another AAPL - until all of their well-heeled friends have accumulated as many shares as they can afford at the lowest price the analysts can engineer.