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LakeshoreLeo1953

04/01/23 9:57 AM

#409441 RE: 12x #409439

Not THAT dated and very likely optimistic given inflation.
Certainly puts supposed 140M in perspective given needs.
Betting a P3 will not be needed is INSANE.
Perhaps Anavex can get a loan from LTB, or at least borrow some shares.

Steady_T

04/01/23 9:10 PM

#409522 RE: 12x #409439

Why commit millions of $ to trials that may not be needed? Wait a few months and find out if that amount of money can be used elsewhere.

Leqembi was AA on a P2 trial.

Doc328

04/02/23 9:16 AM

#409551 RE: 12x #409439

The 130k per patient includes many anti-amyloid mAb trials. These are much more expensive than non-amyloid lowering trials due to imaging costs. As an example the lecanemab 18 month trial included 5 PET scans for amyloid, 2 Pet scans for tau and 6 MRIs for safety. At $5000/PET and $3000/ MRI plus 30-35% overhead you are talking about $70-75k just for the imaging at the sites. The rest of the study for the sites would be an additional +/- 20k. And that is just for the patients who completed. For every enrolled patient, there were 2.5 screen failures. As many failures were due to not having AD pathology on PET or vascular or other pathology on MRI that could affect cognition, throw in another 20k per enrolled patient for the screen failed patient - very quickly we are up to 105-115k to the site for each successfully enrolled patient. Additionally, the CRO takes their cut for management/oversight of the trial, central labs, central imaging review, statistical analysis, etc. Easily 30k more for the complex studies.

Anavex's AD trial, if run in the US with just a single PET and single MRI at screen and being 12 not 18 months would cost +/- 25k to the site and +/- 15k to the CRO or 1/3 the cost. In AU, there is a 40% tax rebate for money spent in AU, the cost would be only +/- 24k/patient.

So if Anavex could do an entire AD P3 with 1000 patients in AU, they would only spend 24 million. However, in order to complete the study in this decade, they will need at least 2/3 the patients in other countries. Germany and France are just slightly less expensive than the US but many studies will have some sites in Eastern Europe which, I have been told is about 30-40% less than US (though not without peril as one study I am in had multiple Ukraine and Russian sites complicating matters)