I think some of the analogies that ADRO is like this or ADXS islike that are somewhat silly but LOL, I hope ADXS is like google myself.
The information on this page is current as of April 1 2015.
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION
Subpart C--Administrative Actions
Sec. 312.42 Clinical holds and requests for modification.
General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjects may not be given the investigational drug. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and placed on the investigational drug; patients already in the study should be taken off therapy involving the investigational drug unless specifically permitted by FDA in the interest of patient safety.
"Count your blessings" Something we all to often forget to do. As I think about it now, I have a great many things to be thankful for, GL2U & A
Do we know for sure the response the OCT 6 response was what the FDA calls a "complete response" ? No we don't. I got the Oct 1st date of the hold and the Oct 6th date that ADXS responded by scouring news articles looking for information that I felt DOC should have provided. I believe you are right that the process is confidential but don't know that for a fact. I don't know but I think the hold will be lifted once the FDA and the company agree on mitigation factors to ensure that no attenuated listeria remains in the body after treatments have been given for fighting the cancer. That news will come out when the hold is lifted which I suspect will release a flood of news in the first quarter, which means we simply have to grit our teeth as ADXS's MC in relation to its peers looks absurd. Patience will be rewarded. GL2U & A
The hold was initiated Oct 1st and ADXS reponded Oct 6th, the FDA had 30 days to respond to the response commencing on the 6th of Oct. They are already overdue but I don't want to waste time quibbling about the date just lift the hold and lets get on with it
We often vent our frustrations along with our opinions but its not simply about a ROI(return on investment) but the hope that this small company ends the curse of cancer that not only ravages the individual afflicted but their families as well as they unfortunately witness the slow and painful death of someone they love under the current standard of care. I pray that ADXS has found the cure not simply for the potential wealth it may bring my paltry investment but for the second chance at life it might bring thousands of individuals and their families. NOW THAT WOULD BE A HECK OF A CHRISTMAS GIFT. GLTA
tx.farmer, bullishonidev, ironyworks, mcbridetina,bourbon_on_my_cornflakes, blueyedcatch, prd747400, ignatiusreilly35, chinaman.nyc2003, mpreorder, fbg0316, hdwrsft,
wasbill, kyndiloh1, batermere, mypekeispooped, branruss369, gajj_4, jamesfox117,
jamessalmon, wisad or wizad and last but not least, legrande_merde, and the corporatelawyerguy
all of you had a very happy thanksgiving with your families and that you all have a VERY MERRY CHRISTMAS AND PROSPEROUS NEW YEAR, IF I LEFT ANYBODY OUT, THE OMISSION WAS UNINTENTIONAL, BUT TO EVERYONE ON THIS BOARD ALL THE BEST WISHES FOR YOUR HAPPINESS AND HEALTH THIS HOLIDAY SEASON, TO ANYONE TO WHOM i'VE POSTED AN UNKIND REPLY, FORGIVE ME, GOD MAY HAVE UNLIMITED PATIENCE I UNFORTUNATELY DON'T, PLEASE ACCEPT MY APOLOGIES FOR ANY HARSH REMARKS and my firm resolve to attempt in the new year to keep it civil no matter how stupid I may think anyone's post might be. GOOD LUCK TO YOU ALL.
SINCERELY YOURS, IMPRVNGMYAVG
i DON'T THINK HE'S CRYING AS MUCH AS i THINK HE'S GIVING VOICE TO THE FRUSTRATION MANY OF US FEEL WITH THE DAILY UP AND DOWN 60 AND 70 CENT PRICE ACTION.I don't know it all, none of us do, but I for one, would really appreciate more news on the status of the hold as the FDAs SO CALLED 30 DAY TIME LIMIT IS UP. JMHO
To be sure communication is not their strong suit. I don't know as I'd go so far as to replace them, but LTSH VALUE in light of some of the insider deals and private placements leads me to think that it is not one of their higher priorities. There is no excuse for us to be lagging ADRO.JMHO but who am I; just a retail investor not one of those institutions that can buy millions of shares, So I suffer no delusions where I stand with regard to SH value, other than the big money expects a payday or Danny boy will be gone.I just need to hang on long enough to be their when the big boys get theirs and make sure I'm standing in line when they do. GLTA.
I've seen enough people allow their egos to get ahead of their talent and abilities to know that it is something I would prefer not to emulate. So I try to keep my own ego in check and avoid falling in love with my own ideas or opinions. Keeping in mind I have been wrong more times than I might care to admit. A little humility never hurt anyone, often being an unappreciated virtue.Have a great day and a Happy Thanksgiving with your family and close relatives. Also a VERY MERRY CHRISTMAS. GL2U& A.
I can't imagine that mgmt or big institutions have that little to do or care a whit about ordinary retail investors like ourselves
Then I guess your on the wrong board and your post was a mistake as you thought you were talking to the Lexus crowd. That's ok sometime in the first quarter we'll be driving Benz's and Ferraris while you still in your Lexus.
LOL, I most definitely agree, discouraging when companies like KBIO which were on the verge of liquidating are trading at $26.25, makes no rational sense
"bsing", LOL, must be a new word around here, at first I thought you were misspelling "being" , then the light came on in my head and realized you meant "no BSing"(bull shetting) rule. I am most definitely not the sharpest pencil in the box.;-)))))
"I am a new shareholder and this board is getting depressing."Well many of us are not new, but LTSHs so spare us your lectures. The price action has been depressing on that we might agree. The FDA is what it is, mgmt's communication skills and damage control during the course of this hold has hardly been stellar but GL2U & A
Mr. Shet I guess you aren't paying attention, New Jersey just gave them 1.6 million in tax credits. FOS, PIZ AND VINEGAR AS ALWAYS. SSDD.
"Any negative feedback or pointing out big fundemental problems that are FACTUAL is prohibited on this board." LOL,OMG and here I thought RATIONAL REASONABLE, CIVIL, INSIGHTFUL, THOUGHTFUL, AND INFORMATIVE DISCUSSION of available facts, occassionably with a little humor, were the order of the day, forgive me please didn't mean to be a debbie downer. ;-)))