Replies to post #50499 on Ayala Pharmaceuticals Inc (ADXS)

[hovacre]

No control group at all, as the study was designed specifically to test safety of the approach. The efficacy findings were secondary, and no clinician will take them seriously before validation in a larger cohort of patients.

However, it's worth noting that with this kind of safety profile, if ADXS gets any kind of significant improvement in recurrence-free survival in a larger study, it would likely be a strong contender for wide adoption, as the risk-benefit of the approach would be lopsided.

As it stands, there's no way to tell for sure if these efficacy findings are better than what have been observed in larger, randomized trials of chemoradiation alone.

[raja48185]

Good to know that the results are encouraging - irrespective of sample size or any other issue.

But this does not change anything in the short term. Even if they were to run a larger trial, starting today and the results were mind blowing, it is going to take some time for that to happen - may be at least 2 years.

What is important now is, how long before the company makes noises to raise cash (that is being depleted)? Can they sell HER2 and get cash, before cash crisis? Can they file for EU AND find a partner who is willing to part with millions and boost the cash position.

My take is that during the shareholder meeting sometime in April, management will probably have the EU filing done by then and along with it, use the encouraging results of anal trial among other things, to effect a dilution.