Ayala Pharmaceuticals Inc (ADXS)

[Dragon Lady]

NEO HAS an FDA "cleared" IND...SEC 10-Q:

https://www.sec.gov/Archives/edgar/data/1100397/000149315217010463/form10q.htm


Not sure what a "FDA cleared application" means exactly...not familiar with that side of FDA regs?

Most recent filed SEC 10-Q, PAGE F-6:

"
ADXS-NEO is the Company’s individual Lm-based antigen delivery product combined with a fusion protein based on information captured by comparing a patient’s own DNA with the DNA from that patient’s tumor. The FDA has cleared the Company’s IND application for clinical investigation of a new precision immunotherapy for the treatment of cancers. The Company plans to initiate a Phase 1 study in first half of 2018."

FIRST HALF 2018 just to get the phase I started...man, these guys seem Sllooooow at everything they do ??? 100 plus employees now...and it can be anywhere from Jan to June 30th to "start" a phase I on NEO ?

I still "don't get it", what we're getting for our money with this 100 plus employee gig from the house that DANNO BUILT ?

Can they put ANYTHING on the HOT or URGENT LIST and like really move- like they got a damn fire under their butts? Are they working 12 hour days, 5 days a week and putting in some Saturday hours too... for all them stock perks and goodies and benis for "BEST PLACE TO WORK" a blah blah ?