Ann: Presentation of BIT225-009 HIV-1 Phase 2 Data, page-580

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Davisite

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16/11/18

23:10

Post #: 36539983
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Originally posted by EML333 ↑

Originally posted by Davisite
MSB is a classic case of the market not seeing what was shown and not understanding the results. Listening to the conference call even the large institutional investors misunderstood the results. It is quite complex to follow what happened in the trial, but the results actually came out much better than they expected. The trial should have failed because the patient population got changed due to problems with one brand of LVAD that filled the trial with patients that can't be tested for weaning because they are not old or sick enough.

They got lucky in that the treatment robustly stopped intestinal bleeding in all the patients. This is something they can go to the FDA and get approval for in the orphan population. If the trial objectives had succeed and not shown this anti-bleeding effect they would have not been able to get approval - the FDA told them that weening was not clinically relevant in this patient population.

The patients that were old and sick and where the treatment showed an effect on weening are the patient type that are in their phase 3 trial. The trial was actually a great success (if for unexpected reasons), but everyone thinks it is a failure.

BIT's trial failed the primary objective (reducing plasma HIV levels) and the market thinks it was a smashing success because they saw some effect of unknown clinical utility on some of the secondary objectives.
Do you think it could be due to the small number of patients. I agree it’s not a big enough cohort

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They mentioned in the conference call that it was about as big a trial that could be organised - something like 5% of all the patients in the world. The real problem ws the patient population didn't match the trial plan - they certainly got lucky with the anti-bleeding effect as that data looks rock solid and the FDA is very likely to approve on that basis - in the end it doesn't matter why a patient is using your treatment as long as they are getting a benefit.

BIT Price at posting: 21.0¢ Sentiment: None Disclosure: Not Held
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