Replies to post #47192 on Ayala Pharmaceuticals Inc (ADXS)

[CATTDOGG12347]

The tax credit is paying for a lot of the staff, we may not have gotten the tax credit without doing the hiring we did.

[BarrellofHay]

Latest AXAL trial being canceled is very worrisome. Her2 and ADRO failures is causing me to rethink my investment in LM. I also do not like the way the company is communicating. One line in the 10K instead of a press release. Furthermore, the results of Phase 2 stage 1 anal were not explained in a press release at all. I still do not fully understand the results because they were never properly exlained leading me to have to do research and read articles that I don't understand fully and try to understand terms I do not fully understand. And don't tell me that I should know this stuff fully "or I have no business investing in a biotech" if thats the case then 99.99% of people would have no business investing and there would be no money in this sector. So here are the Axal anal results:

"One pt (3.5%) had a durable partial response lasting > 6 months (after progression on prior anti-PD-1 therapy) and 7 pts had stable disease (24%). Disease control rate was 28%. The current KM 6-month PFS estimate is 22%. Common (= 30%) treatment related AEs (TRAEs) were grade 1-2 chills/rigors, fever, hypotension and vomiting. Grade 3 TRAEs of cytokine related syndrome (n?=?1; SAE), infusion related reactions (n?=?2; 1 SAE) and hypotension (n?=?2; 1 SAE) were reported. "

They were released some time ago and led to a lot of discussion speculation on this board including myself. I never fully understood the most relevant point and thats: is this good?? Or is this better than standard care?? is the PFS estimate the real number to look at??? Why was this never explained in a press release?? I NOW have to assume it is NOT good given the 10K. If it was, they OR a partner would be pursuing.

Same goes for HER2. only data we have is for dogs and people are not dogs. We do know that data has not been released. But if it was leaning "good" they would not have scrapped it and found a partner or a buyer by now.

so what do they have to sink their teeth into only a small study for AXAL cervical. Thats what they had when they were on the OTC with India data that was actually slightly better. So, those who say the science is much better than back then??? don't get it?? nothing has changed. if anything data is slightly worse. NEO and HOT - still preclinical and many many years and dilutions away.

EU approval would be great but is anyone else worried that it will only be based on Phase II data without placebo group? Will the EU really want to approve this without Phase III?

Head and neck data just as mysterious

Thinking of moving half my ADXS to a better way underpriced bet: BLRX

[pharmeng]

Now they committed the capital expenses to their own manufacturing facility, there is a lot of headcount that goes with it (operations, quality, microbiology, manufacturing, analytical testing, etc). If they laid everyone off they would have to outsource these activities which still cost a lot, and then waste the investment they put in.

It's difficult for them to undo this at this point. I hope they get a permanent CEO soon, but Tony is likely doing the best he can, which is focusing the clinical development programs. Lot of large Pharmas are going through this process as well and out-licensing programs, doesn't necessarily mean the drug is a poor performer.

[Simple Steve]

Barrel, that's EXACTLY what I've been thinking recently too. I've been invested in this company for 3 years now and I feel the company has gained a thing. We're just spinning our wheels. Her2 gone. AXAL anal, gone. Now left is cervical and NEO. NEO is quite promising but how long before it goes to market? Many years. And can we even be sure anything will ever come of these drugs? What if these eventually go by the wayside too? Now its easy to see why this stock has tanked and no BP seems interested.