GVHD in US, page-45

I have had a look at the results from the LVAD trial in the press release from MSB. Results showed a reduction in incidence of GI bleeding from 15.9 to 3.8 per 100 patient months and a reduction in hospitalisation for GI bleeding from 0.21 to 0.07 per 100 patient months.

@angelus512

Yes there results are statistically significant (see p values in the press release) but the FDA will assess:

 - Is the quality of the data good enough? or does MSB need to repeat the trial to confirm - my feeling is yes

 - Is the magnitude of effect enough to justify the expense? this will also be asked by the health insurers. Looking at the data above there is an absolute risk reduction of 0.14 admissions per 100 patient months. Is that effect enough to justify the cost? If we assume the treatment costs $100k then each admission would need to cost almost $1M to justify the expense so I think not.

Its easy to read "a statistically significant result" and see a reduction of bleeding in the magnitude of 65-75%, however the underlying incidence and absolute risk reduction are at least as important. For example elephant repellent would be super handy in South Africa but fairly useless here.

Please keen in mind that I am no expert in FDA approval and would be happy to see this go ahead (I am a SH too) however I am a doctor and have read probably thousands of medical journal articles. So please feel free to ignore anything I say about FDA approval.

Meanwhile lets get excited for GVHD approval and the chronic back pain read out!