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   Biotech / MedicalImmunomedics (IMMU) - moderated


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To: weatherproof who wrote (45935)4/28/2018 10:18:33 AM
From: Smoke Reader
1 Recommendation   of 58497
 
For what is worth, I am quoting from the Glossary of Terms at ClinicalTrials.gov... clinicaltrials.gov
***START QUOTE***
Recruitment status: clinical study
Not yet recruiting: The study has not started recruiting participants.
Recruiting: The study is currently recruiting participants.
Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Suspended: The study has stopped early but may start again.
Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
Withdrawn: The study stopped early, before enrolling its first participant.
Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years
***END QUOTE***

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To: Smoke Reader who wrote (45936)4/28/2018 11:12:44 AM
From: weatherproof
4 Recommendations   of 58497
 
Thanks, Smokey. I should have looked that up before I started my last post, but I suppose it doesn't fight with my working theory.

Friends have asked me if they should buy the stock now. I cannot answer that for anyone, as I do not know their financial situation, their current investment portfolio in terms of how diverse it is, or one's tolerance for risk. Nor am I qualified to answer such questions. What I will say is that the manner in which IMMU and others (e.g. Royal Pharma) are investing in ramping up for commercialization of IMMU-132 before approval, suggests that there is an extreme level of confidence pointing toward accelerated approval being imminent. If you've ever cursed yourself for not buying, or buying in early and then selling prematurely, Apple or Google in the beginning stages of those issues, I suppose this is what those foregone opportunities looked like way back when. Does that mean we're definitely going to the moon, that there is no risk? Of course not! I'm simply suggesting that this is an exciting time in IMMU's life cycle to be in it. We're at the intersection of fortune and folly.

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To: weatherproof who wrote (45937)4/28/2018 11:31:03 AM
From: Renmanco
3 Recommendations   of 58497
 
One of the most challenging aspects of investing in these early stage companies is dealing with the volatility....and the accompanying psychology.
It is not uncommon for such stocks to have swings of more than 30, 40, 50%....or more on an irregular but recurring basis and the temptation/fear is that "someone knows something that I do not....and I had best either nail down my profit and/or sell before the loss becomes greater."
I great anchor at these times is to reexamine the company's basic fundamental story, including a review of insider ownership and see what those really in the know are doing with their shares save for taking small increments off the table periodically to diversify what are typically oversized positions.
I recall doing a study of Medtronic about 20 years ago tracing its IPO through the date of my study. The number of 50%++ swings was very frightful to say the least but the overall compound return over 30 years was astounding. Lesson learned.
Just look at the volatility of IMMU since its IPO. Huge price swings...and no real net progress. Finally, we had a series of terrific catalysts and I suspect they are only the beginning of what I'll call a redemption for long-term holders. The fact that G and S have been exiting is another perverse catalyst that I really like seeing.

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To: drtom1234 who wrote (45929)4/28/2018 11:49:18 AM
From: plhky3465
2 Recommendations   of 58497
 
Is it possible that any of this is related to the content of Fitz's post 44636 which i copy below??

FDA to Allow Quicker Approval of Some Promising Cancer Drugs
Commissioner Scott Gottlieb says there will be more cases of drugs that show early and large potential.

By Thomas M. Burton, Wall Street Journal

The Food and Drug Administration plans to allow quick approval of some cancer drugs if they show early and “outsized” survival benefits for patients even in small studies, the FDA’s commissioner said Thursday.

Scott Gottlieb told the House Energy and Commerce subcommittee on health that the agency expects to see this situation more, given the advent of drugs that precisely target the genetic underpinnings of diseases.

“We’re going to see more such cases,” he told the committee members, “where a new drug offers an outsized survival benefit in a selected population of patients in a smaller, early-stage clinical trial.” Such cases, he said, “are compelling us to explore new ways to facilitate and expedite the development and review of these products.”

His concept is essentially an expansion of what the FDA currently does in what the agency calls accelerated approval. It now can approve a drug based on early evidence but require that the manufacturer do a confirmatory study to keep the medicine on the market.

Currently, such approvals are based on endpoints like tumor shrinkage that are believed to be “surrogates” for clinical benefits, such as survival. Dr. Gottlieb’s new proposal would be based directly on overall survival “in a rare or deadly cancer,” he testified. The concept could be used for drugs that don’t have FDA approval or to expand the approval already in existence.

Source: wsj.com

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To: winners18 who wrote (45931)4/28/2018 3:24:32 PM
From: erippetoe
2 Recommendations   of 58497
 
Wednesday

11:25 The Promise and Challenge of T-Cell-Redirecting Bispecific Antibodies Made by the DNL? Platform

Chien-Hsing Ken Chang, PhD, Vice President, Research & Development, Immunomedics, Inc.

Accumulating evidence has indicated the antitumor immunity of T cells induced upon ligation with a bsAb to target tumor cells also incurs a concurrent activation of various cell-bound as well as -secreted factors to promote tumor growth. Elucidating the relative contribution of each of these factors to the destruction and protection of tumor presents a challenge, and provides insights into selecting optimal combination therapy with T cells redirected by bsAbs.

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To: weatherproof who wrote (45937)4/28/2018 6:00:58 PM
From: idahoranch1
   of 58497
 
Reading the preceding post and then skipping back to yours Weather, if we have success with 132 to the degree some of believe is very possible, and then the T-cell director turns out successful, then we would be looking at apple or google numbers. It’s a moonshot though, and far far out on my radar although I’m not ignoring it.

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To: weatherproof who wrote (45935)4/28/2018 7:42:59 PM
From: drtom1234
6 Recommendations   of 58497
 
As I recall, while the basket study may have paused with TNBC, it always stayed "active" on the clinical trials website. Generally, when a trial gets changed to "active, not recruiting", it means that they are continuing to treat and follow the patients they have already accrued, but will not be recruiting further patients to the study. Generally, a trial will not go back to "active" once it's changed to "active, not recruiting". That's why I find this so confusing. To my mind, the cost of initiating new P2 trials when you had a perfectly good one running makes no sense. The two stage approach, assuming that is the plan, could easily have been done within the basket trial without added cost. So, again, as best I can tell, either they've already accrued enough to satisfy AA requirements, or, they aren't planning on applying for AA, and moving forward with a P3 in the standard way. I suppose another alternative is that they are setting up a P2/P3 study, where they finish off the P2 numbers they need for AA, then move straight into accrual for the confirmatory P3 while the application for AA is going through the FDA process. So, using TNBC for example. The initial basket study numbers to get BTD were, I believe around 58. If the company had gone the P2/P3 combo study route, they could have accrued the additional 42 patients requested by the FDA, and then zoomed straight into the P3 while AA was pending. Of course, the risk here is that if the 42 patients hadn't supported AA, you're on the hook for a P3 study, and have to eat the costs involved with shutting that down, or continuing it without moving forward with the AA application. Hopefully the company will offer some clarity in 36 days.

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To: plhky3465 who wrote (45939)4/28/2018 7:45:10 PM
From: drtom1234
   of 58497
 
Unfortunately, no way of knowing that at this point. I'm not aware, however, of any codified changes in how the FDA would approve drugs faster, which I believe would be necessary in such a bureaucratic agency. We'll know more soon, that's for sure.

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To: erippetoe who wrote (45940)4/28/2018 11:51:38 PM
From: duwhee
2 Recommendations   of 58497
 
Chien-Hsing Ken Chang, PhD, Vice President, Research & Development, Immunomedics, Inc.

Has been a rock star for us.

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To: drtom1234 who wrote (45943)4/28/2018 11:54:17 PM
From: idahoranch1
2 Recommendations   of 58497
 
Whatever the plans, I’m sure it’s because of communication with FDA and how they prefer the company to proceed given the multiple indications 132 targets. The company had to be requesting the best greased skids to get as many indications approved in the best timeframe they could. Hopefully it’s the best options for us for the best pathways. It would be great to get a pleasant surprise, but I’m going to try to avoid raising my expectations on that to avoid disappointment.

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