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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?


To: MrChaos who wrote (46009)5/5/2018 9:46:59 PM
From: idahoranch15 Recommendations

Recommended By
captcobra1
drtom1234
ladyPI
MrChaos
patlawche11

  Respond to of 63276
 
It’s on my list of concerns, somewhere below WW3 and a collapse of the internet, another dust bowl and food shortage. All are possible, but at least with the phase lll trial we have a lot of data to put into the mix, it’s not just a shot in the dark. 132 shrinks tumors in a significant % of patients in several indications and a very good safety profile.

For now, mostly looking forward to the release of the abstracts on May 16th. That’s going to be an interesting bit of information to add to what we have.



To: MrChaos who wrote (46009)5/5/2018 11:13:16 PM
From: Mikeim2 Recommendations

Recommended By
bobbseytwins2001
patlawche11

  Respond to of 63276
 
Royalty Pharma and Phell would not be in the mix if there were any doubts. The only troublesome question is at which price do we average up



To: MrChaos who wrote (46009)5/6/2018 12:21:24 PM
From: erickerickson2 Recommendations

Recommended By
allatwwk
ladyPI

  Read Replies (1) | Respond to of 63276
 
I expect that a number of people (myself included) see the BLA approval and the PIII as make-or-break points. One strategy would be to take some holdings off the table before either of those events; being denied BLA or failing PIII would both be pretty painful PPS wise. The first is recoverable, the second less so.

How likely negative outcomes for either of those are is a very good question, most of us here have lots of confidence that both those events will turn out positively. Mr. Ranch's post expresses the sentiment well. And, as others have posted there's some confidence-boosting from outside our little group; the Royal deal is one.

Personally, given how over-weight I am in IMMMU, I'm likely taking a significant percent of my holdings off the table sometime this summer and letting the rest ride until the show plays out. I'm expecting the BLA submission and the ASCO presentations to at least keep the PPS near current levels, and hoping they'll give it a boost.

BTW, for all you old timers. Imagine if you will that there's a pre-ASCO PPS increase that is sustained after the conference! Has that ever happened in the past?

Cashing out the rest waits on, well, a number of possibilities:
- the remaining shares are worth a gazillion dollars
- IMMU gets sold
- I want to buy a 16m catamaran and retire to the tropics
- my shares are worth enough to buy my own tropical island and live there when it's cold (Maui would do).
- I need to set up a trust fund for my grandson
- I need to pay for in-home elder-care
- IMMU implodes
- the new board loots the treasury and absconds to a country with no extradition treaty
- my daughter becomes my guardian and decides to do something rational with my investments
- <insert favorite "life changing event" here>

Were IMMU a small part of a well-balanced portfolio I wouldn't sell any anytime soon, certainly not before the BLA decision. Given that it's a very large percentage of a horribly un-balanced portfolio, the calculations change quite a bit....

Enough maundering on a Sunday morning.



To: MrChaos who wrote (46009)5/6/2018 1:32:12 PM
From: li35119 Recommendations

Recommended By
captcobra1
corndog
Fitzhughlaw
idahoranch1
ladyPI

and 4 more members

  Respond to of 63276
 
> It doesn't seem to worry anyone.

Right.

In the anticipated order of events, the filing for accelerated approval happens within a month, and the decision is received by year end. Presuming approval, marketing starts immediately, perhaps as soon as December 2018.

And the Phase III ASCENT trial? According to ClinicalTrials.gov, it won't be over until June 2020. clinicaltrials.gov That means that even if it doesn't make its endpoints (which is not likely), Sacituzumab Govitecan will have been on the market for at least two years before the FDA would rescind approval.

In those two years, one might expect SG to develop a following—not only for the label indication of third-line treatment for TNBC, but for off-label uses for other stages and for other cancers. It's politically difficult to rescind approval of a drug that many people believe is a lifesaver if there are no better options and if it's not doing overt harm.

So no, I'm not particularly worried about the outcome of ASCENT. The big gamble is for accelerated approval in the first place.