RAC

1.74%

$1.47 race oncology ltd

Pillar 2 - Breast Cancer, page-88

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mcexplorer

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14/03/21

00:01

Post #: 51749167
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Originally posted by wombat777: ↑

Off the top of my head I think these are the main reasons any clinical trial can fail:

inadequate planning

focusing on the wrong indications ( could impact recruitment due the competition for patients )

getting patient selection criteria wrong

getting drug dosing protocol wrong

selecting the wrong primary and secondary endpoints

selecting the wrong people to run the trial

selecting the wrong trial sites ( could impact recruitment )

not taking enough care with paperwork necessary to commence a trial

failing to recruit patients in an acceptable timeframe ( related to factors above )

drug not safe

drug not effective

We know from the history Bisantrene is safe and effective. It’s actually quite hard to find compounds that go the distance to become an approved drug ( and Bisantrene was approved in France for AML ).

There are many, many factors outside the safety and effectiveness of a drug that could cause a trial to fail.

RACE are unlikely to be the ones seeking approval. RACE’s focus is on getting the preparation right such that a potential buyer will be confident approval is achievable based on preclinical data and/or readout data from trials.

Expand

Yes, initial plan of RAC was to obtain PRV (priotity review voucher) from FDA and then sell it to big pharma for about US$150m, almost 36% of RAC current MC, A$550m. Maybe PRV sale is not RACs interest anymore.

But this PRV does will increase MC by 36% LOL, i.e. sp = $5.44
Last edited by mcexplorer: 14/03/21

RAC Price at posting: $4.00 Sentiment: Buy Disclosure: Held
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Pillar 2 - Breast Cancer, page-88

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Pillar 2 - Breast Cancer, page-88

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