Friday, October 24, 2014 1:37:41 PM
And realize that we're dealing with a drug (ifosfamide) that has already been approved by the FDA... so we don't need a huge study because we're not dealing with side effects... it's a proof of concept type thing... which Cell in a Box... is passing...
They don't need hundreds of patients to prove the cells do in fact work inside the capsules if they work on 26 people then it's proof the concept works...
If Ifosfamide is already approved so the need to do a long... many patient trials for toxicity purposes (which is usually the reason trials are longer and have more patients) isn't there...
If NVLX was trying to get a new drug approved yes... the number of patients would matter because we'd have to present the FDA with an extensive toxicity study... but already approved drugs nope don't need it...
And they've already proven no side effects in P I/II which is all they needed to do along with proving that the Cell in a Box wouldn't migrate or mutate... proven!!!
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