Replies to post #27295 on Ayala Pharmaceuticals Inc (fka ADXS)

[DewDiligence]

In reply to your prompt: Yes, the lack of control arms in the trials completed to date is utterly germane to the valuation of the stock. Many investors do not accept historical controls as proof of concept that a drug works.

One even has to wonder why, after so many years, ADXS does not yet have a completed trial with a bona fide control arm. AIM2CERV does have a control arm, but the data from AIM2CERV will (conveniently, a cynic might say) not read out until 2020.

p.s. I've posted on numerous occasions that ADXS-NEO is the main reason I'm long the stock (#msg-132170909).

[ignatiusrielly35]

Who knows more about cervical cancer than GOG? They are mightily impressed, and they base that on the P2 results. In addition, the AIM2Cerv Phase 2 met or exceeded all endpoints and is now in Phase 3. Excellent results thus far in the anal cancer trial as well (92% positive response). Clearance from the EMA to apply for early EU approval. Compare to ADRO, with its recent failed Phase 3 and yet 3x the market cap. ADXS is being manipulated, period.

[Crcook]

OK Barrell.....while true there have been NO trials with control arms, double blinded, etc.----study carefully the RTOG and GOG trials and results. In GOG 265 Phase 2 using exactly same design and criteria as many others over many years the GOG trial revealed AXAL to compare favorably (38% to 56% OR) to all including the blockbuster drug AVASTIN (30% OR)...and as I recall, this was with much worse off patients some or most of whom had already failed with AVASTIN. Then there is the 10/10 CR in Anal trial now approaching 36 months with ~89% CR/OR vs 45% 3Yr CR/OR for SOC. And the 8/8 CR in H&N trials............all without control arms, but not anything to sneeze at or just ignore as in right off to chance!
The Aim2cerve Phase 3 is the first axal trial with blind controls, and I'm sure you are well aware of that.

GLTAL's

[zzaatt]

Was being provocative and hoping somebody would "set me straight"

You overestimate the value of your "observations".
Many people feel that there was no "point" that was worth
responding to. All your objections have been raised hundreds
of times on this board (and I have been here for less than three months).

BTW, "being provocative" is not a sincere approach! Try being honest!