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Come on, things take time. It took 2504 days, or 6.86 years, to accomplish the described goal declared in the attached link.
winkels,
It's way to late, but I feel compelled to respond based upon your retort, which is quoted below:
"Some people just don't get it (or choose not to get it)
This company is not about bringing Absssi to market..
or Bom
or an IBD drug..
or a B topical..
but of course until the ink dries..
EVERYTHING must be left on the table..
that is why there is a possible scenario where
IPIX COULD sell one indication.. to fund the others..
but that is not the plan (imo) "
You seem to possess great knowledge of the company's(ipix) plan.
What do you suspect the plan to be?
Good for retail shareholders, or not so good?
Are you a retail shareholder, or not?
Thx
Looks like Leo has the bases covered though.
Thx, Got it.
Thought I'd toss this out there b4 hitting the hay. The jibberish is getting quite boring.
What are the odds of a relationship(siblings, couple, cousins,?)?
http://www.sun-sentinel.com/local/broward/fl-sb-judge-bullying-inmate-dies-20180420-story.html
They(LE and she) could not be closer in age.
KMBJN
I agree, those 3 things are most important. Out of curiosity, have you ever seen one come through requesting compassionate use for psoriasis for psoriasis?
After listening to the 3/17/16 fda patient-focused drug development conference for psoriasis, I was blown away by how much those with psoriasis go through- on many different levels. It was clear by the fda panelists comments during the conference, but particularly at the conclusion, that they were blown away as well.
If P2b data is good, I could easily see P being requested for use via compassionate use. Many of the patients who spoke of how many different medicines they've been prescribed over the years. Others spoke of their concern of health side effects in taking these drugs,and they are real concerns such as liver disease, diabetes, heart disease to name just a few, there were many others stated.
I've provided the link again in the event you hadn't listened(there is a link for the transcript of the session at the bottom) and may want to. It's long, I listed in sections as time allowed over a few days(5 hours total +-).
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm
"B has not been cleared by the FDA. Meaning patients outside of trials are not permitted to use."
I don't think so.
https://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm#what-does-fda-consider
Excerpts from the link below
What does the FDA Consider When Reviewing my Request?
When a treating physician requests expanded access to an investigational drug , the FDA must determine if the patient or patients to be treated have a serious or immediately life-threatening disease or condition. The Code of Federal Regulations (21 CFR Part 312.300) details how expanded access can be granted and what steps the FDA needs to follow.
Doctors Reviewing Expanded Access Requrest
It is important to have a discussion with your physician or healthcare provider to see if your current disease or condition can be defined as either:
A serious disease/condition: a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one; or
Immediately life threatening: a disease or condition is a stage of disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
The FDA must also determine that:
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
The patient cannot obtain the drug under another IND or protocol.
The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated.
Providing the investigational drug will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.
If I Meet the Criteria, Will I Qualify for Expanded Access/Compassionate Use to a Drug?
Not necessarily. Even if you meet the criteria, there may still be obstacles.
Your physician may not be able to obtain expanded access for you because of your medical history or the risks associated with taking an investigational drug. Your physician must determine that the probable risk from the drug is not greater than the probable risk from the disease.
Your physician may not be willing to manage the use of an investigational drug.
The company that makes the drug is not required to offer it outside their clinical trials, and they may not be willing or able to do so.
The company may not have enough of the drug available for all patients requesting expanded access. Some companies establish a lottery system to determine which patients will have treatment access. Others make the decision on a case-by-case basis.
Investigational drugs are expensive to make. The drug company may request authorization from FDA to charge you the direct costs of making the drug available, such as manufacturing and shipping, and indirect costs, such as reporting and IRB approval, or it may elect to cover the cost. Remember that most insurance companies will not pay for access to an investigational drug and that there may be additional cost for administering them and then for monitoring of the IND by your hospital or healthcare provider. These costs do not require FDA authorization. It is important that you and your physician consider the cost of the investigational drug and the medical services associated with its use that are not covered by third-party payers such as insurance or Medicare.
"So manufacturing of B is still years away."
Not if patients who were under the B-OM study(or any other B study have requested to use the drug because they have exhuasted all others(compassionate use).
Don't know if you listened to the patient focused drug development meeting held by the fda in D.C back on 3/16/17 (i refered to it and attached the below link a few days ago. Scroll down to the meeting materials section(about 3/4's down the page and click on meeting recording 1(morning session) and meeting recording 2(afternoon). Though meeting addressed psoriasis patients, it can be applied to many clinical trials I would think.
Listen to the feedback the fda gets from the patients that are there,phone in, or respond via internet. Many of the patients who participated in a clinical trial expressed complete frustration that they could continue to use the trial drug when it worked for the patient because it was not approved.
You'll hear, more than once, from the fda administrators in attendance, as well as physicians, how surprised they were to hear the difficulty(pain, ithiness, swelling, organ damage, exhaustion from lack of sleep, etc) and praised those who shared their experience and promised their(the patients) efforts will help shape future trial design and fda policy for psoriasis(and I suspect other conditions).
www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm
Echo20,
To qoute you
"I was looking for a sign and that was a good sign. Turkeys are a lot of meat. Good fortune then. Maybe good fortune for IPIX. "
I would not eliminate the possibility that it (those turkeys) may be the voices in your head. A definite maybe, which you inserted, not I.
I know nothing(about what shall be unveiled, only what has been reveiled by the company).
Where in the Boston area do you reside? Can't be too far from Beverly.
Trust me, I'm not happy with the company's performance, but I have made my way up there to inquire.
My inquiries were answered with out positive effect on my investment.
At this point I trust what was stated to me personally, or via media(phone, email) to be true but distrust their pr's. All forms of communication can be held to further scrutiny.
biodoc,
Not sure what you're responding to. I asked sox about this:
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm
I just finished listening to "meeting recording 1" in the above link where the fda asks a couple hundred psoriasis patients to describe to them(the fda) what they go through(after introductory fda comments).
You, and anyone on this board who suffers not from psoriasis, are in for earful and education I think.
Anyone would do themselves a favor, even if not invested in this company, and listen.
Sox,
Great post.
What do you think of this?
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm
thx
CanesNH,
Excellent response.
However, I suspect the questionnaires resulted from this fda meeting, held on 3/17/16(St. Paddy's day), to get input from psoriasis patients and the general public who have experience with psoriasis, but have also thought along your line of thinking.
I found the link below last night and will have to listen in intermittently(I'm only as far as the 1st hour into the first recording- meeting ran from ~ 9 or 10 to 4).
I recommend pumpers and bashers, and those honestly frustrated, listen to it.
https://collaboration.fda.gov/p9l99v4eycu/?launcher=false&fcsContent=true&pbMode=normal
Is that the study not registered with clinicaltrials.gov?
great advice- all you that question just call 978 921-4125. They will get back to you.
Be sure to vidio, or audio, record your message.
"IPIX has ~20 CDAs, so there goes your “no one has shown interest” speculation."
The last time I know of that ipix referenced ~20 cda's was in their 1/28/18 pr, nearing 3 mos. ago, i may be wrong(as to last reference of ~20 cda's)- don't think so.
I personally believe the Aspire deal has crushed ipix, and wonder, based upon company pr's/blogs, why no support can be mustered? To me the answer lies in it's brain trust, not deep enough. LE is the first hurdle tripping the potentiality, the next trip hazard is it's bod, bye-bye to them, name some qualified bod's, let AB ,JH, EW(if he's still there) pull this kite up.
BooDog,
Agree 100%.
Don't know how you do it, effectively moderate 7 boards, hold a full time job, and attend to the tasks and chores of everyday life.
One could say since December 2014
tombrady12nh
"No words for what I'm seeing here. Once I would've mortgaged my house on this stock but now I have the feeling it's not any different than my other loser OTCBB picks"
Got me thinking- maybe I'll sell some ipix and put it on Gronk(the horse).
Just hope Gronk(the man) is not the jockey.
IrishGuy256,
Your sentiments have been sung by many here over the years. Have gotten them, for many of us, i believe too many have listened too far and too long.
The big LE can prove me wrong.
Hope you listened to my clip. from the Corries, earlier today.
"The only man I know who behaves sensibly is my tailor. He takes my measurements anew each time he sees me. The rest go on with their old measurements and expect me to fit them."
glty
"His response sounds like a boiler plate response that his secretary was instructed to reply with."
Please don't suggest, or insinuate, that he has a personal secretary, or general secretary. Try getting anyone to answer the phone. I suspect you know this, if not dial 978 921-4125.
Good luck.
ps- the Beverley Cummings Center is a big fish bowl. One can monitor activity (bring food, and if you're on oxygen a couple extra tanks. It's a nice complex with hundreds(thousands?) of businesses.
Twas vacation week. Visited a sibling in the north shore. Inclimate weather. Took the youngen's to explore "The Shoe".
Could be, who knows.
Most rides are enjoyable, others not as much.
The following clip is analogous to returns realized by most ipix investors.
TIAB,
"obv do not have to report every data point at once, could at least put out most impt data first
which they haven't "
I have often thought that as they await word from the CRO, they are honing their skills in other areas at the conference room table.
I associate more as the rope, pulley and barrel of bricks described in the following link which propose be the ipix theme song.
Interesting, thanks for the post. eom
Dane,
Well said.
Blue Fin,
TY for the thoughtful reply.
Reminds me of an old song with the words "don't ask me no questions, and I won't tell you no lies".
Thanks again, I think I found them;)
seek the light,
Perhaps. All I know is you don't design a building foundation to be supported by friction piles in quick sand. This investment has borne a heavy price for many.
Hopefully the stratum firms up before the pile is lost.
Great, thank you. What's Dr. Bertolino's email? I can't find it.
I would think the company(particularly a publicly traded company) would have contact information for investors(email, ext). Like I said, I must be old fashioned. Must be a new way of doing business(don't contact us, we'll contact you)
Suppose I'm old fashioned- still use the phone primarily. "Please enter the name of the party you wish to reach by entering their initials, last name first".
Try it yourself. Dial 978 921-4125 and enter BA(Bertolino, Arthur) after the prompt. "Your party can not be identified" is what you will hear. I know, Bertolino is the new kid on the block- they haven't updated the phone system since his hiring in June of 2016, perhaps?
Must be fun for the BP's trying to reach AB.
Thanks for your keen analysis(supplemented by many maybes and could be's. T'wat is your honest opinion? May be, would be, or is?
I do not expect an answer,but do hope, honestly, for a response. thx
Please respond via your own line items.
TRY getting a response. What is Betolino's contact #? GLTU. Something, in my mind only,is wrong, you whipper snappers, prove me wrong.
Please provide his ipix extension #, or direct # .
TY
I haven't been keeping up with the board much so what is the latest?
Expect the Prurisol Phase 2b trial data to be unblinded by or before Monday April 2, 2018 and the Prurisol Phase 2b trial topline resluts [color=red][/color]to be released by or before Monday April 16, 2018.
Are topline resluts considered to be Beverley's best attribute?
Thanks for the notice George, think I'll stay away.
Wally, Wally, Wally!
Jerry Remy is probably the only other who gets my reference.
If P results are great this will explode(in a good way). I believe(hope) the Aspire deal explains where we are(who can be sure?). Will also give a nod to tiab for referencing time, it's(time) important and critical to the company's and its investor's well being.
Regarding MM's and BP, I won't speculate.
"Do you think that someone that counts everyday (like a child would do) the number of days that have passed since the end of the trial has any credibility ?"
Nothing wrong with tracking one's investments, is there? I suspect most all of use various methods of tracking, and assessing our investments. One of the most important parameters is time. Erhlich references time frequently in his updates, and modifies as need be.
You are, apparently, an engineer and must be quite familiar with scheduling and putting a priority on those tasks(activities) which are on the critical path.
Time is not infinite to most, ignore it and risk the penalty of liquidated damages.
"Why anyone wants to continue to average down here when this stock has been a persistent disappointment is beyond me."?
Fair and honest question. Your likely to get crucified by those part and parcel to what's happening. A picture is worth a thousand words.
Yuk-yuk-yuk,
I believe Drs. Menon, Bertolino, and Mr Erhlich are trying.
TIAB,
Agree with your sentiments. I don't think anyone here(other than shorts) yearns to be at this sp, but FUD is one reason the sp is where it's at. There are other reasons, and management has not been a big help in deflecting negative sentiments. Managements statements offer more (almost unconditional) promise than not, yet the sp declines
A simple question, to which I can not formulate an answer to to date, is why?
Perhaps a question left to Healey and Sullivan? We'll see.
Anybody still buying now has my grudging respect. Me- way too worried about drifting way down from here, even. Although I did enjoy- however briefly- the 50 cent floor mirage.