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   Biotech / MedicalImmunomedics (IMMU) - moderated


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To: sukit who wrote (50222)2/8/2019 10:14:05 PM
From: weatherproof
11 Recommendations   of 57073
 
Typical BLA review time = 10 months; Priority review = 6 months

Form 483's not uncommon, often followed up by future inspections and additional 483's all performed within the standard 10-month time frame

FDA backlog precludes them from performing post-483 re-inspection within the priority review 6-month time frame

Government shutdown exacerbates timing issues

FDA issues CRL to buy time

FDA will perform re-inspection any day now

What's built into the current price is a Class 2 resubmission with its 6-month review.

If the above scenario plays out, stock goes back to $20's

Next best case, FDA classifies resubmission as Class 1, stock goes to $18

Most likely scenario, Class 2 resubmission = Time for IMMU to fix problems plus 6-month FDA review, stock

hovers around present price of $14

Worst case, weatherproof runs out of present stock of Sambuca Romana and has to call it a night

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To: blessedtobehere who wrote (50214)2/8/2019 10:23:57 PM
From: rodneyh07
   of 57073
 
That Is true...

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To: blessedtobehere who wrote (50218)2/8/2019 10:27:25 PM
From: rodneyh07
   of 57073
 
Agree I was banned and the person that I supposedly said bad things attacked my character and I did not...

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To: idahoranch1 who wrote (50210)2/8/2019 10:30:58 PM
From: ladyPI
   of 57073
 
have a witness to the nasty post before admin, I assume, took it down.

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To: allatwwk who wrote (50221)2/8/2019 11:01:14 PM
From: stockdoc77
3 Recommendations   of 57073
 
A little birdie found and sent it along to me. I'll email it to Idaho and the Ronin and some others in the circle of trust. Ask one of them for it if you are interested. It is from Jefferies and also includes some useful benchmark data on timing of FDA actions. The analysis covers 2013 to 2018 drugs with BTD for oncology and hematology.

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To: stockdoc77 who wrote (50227)2/8/2019 11:14:35 PM
From: ladyPI
   of 57073
 
The FDA Is Basically Approving Everything. Here's The Data To Prove It. Thats the title to google. Forbes

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To: blessedtobehere who wrote (50218)2/8/2019 11:26:26 PM
From: JJINV
2 Recommendations   of 57073
 
I would like to say .. I did read that very nasty and inappropriate comment you made to Lady. I even noted it to a few as it was a direct and dis-respectful commentary... and correct, I cannot locate the post as it is no longer ...

We don't have to like everybody in a group, yet it is correct to respect opinion and who they are as a human; usually when we feel a "disgust" towards another we are looking at an aspect of self that wants to be revealed.

Live long an prosper to all! :)

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To: diaperdaddy who wrote (50207)2/8/2019 11:34:42 PM
From: kdd999
1 Recommendation   of 57073
 
Absolutely best post of the year. I laughed out loud for sure at that one!!

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To: jargonweary who wrote (50215)2/8/2019 11:40:21 PM
From: kdd999
   of 57073
 
STOP IT or I am going to stop the car and bash both of your heads in and you can walk the rest of the way home.

Sorry I can only reply to one person, but YOU KNOW WHO YOU ARE!!

GROW UP.

(Please don't ban them, it is actually kinda funny. Reminds me of when my adult sons were 5 and 7 years old on the way to school every morning.)

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To: stockdoc77 who wrote (50227)2/8/2019 11:58:22 PM
From: kdd999
1 Recommendation   of 57073
 
Thank you for clarification. That explains why my count was so low. I included only AA, not BTD and Fast track. Many drugs had all 3, but I did not count unless they had AA. Not that many of those. Lots of BTD and Fast Track. Also Orphan drugs.

If I have time, I will go back and recount, and write down what is on the list. I started to do that, but wasn't sure it was worth the effort. Now I sort of think it is. (I do not fall into either the fda or the mgmt haters, but I do have suspicions on both sides, and I would like to know how often FDA grants AA and approves AA to small biotechs vs. big pharma, because we all know who has the money to buy approval in this world.)

I do think things are cluttered by the govt shutdown. That is unprecedented, and there is no historical norm to compare what happens in that instance.

I hope I am not beating that poor horse.

Understanding our potential future success with FDA is going to be important for me because I intend to be holding considerable shares when they apply for other applications. IMMU needs a team that can do this efficiently because they will be back at the trough for other indications and for combo trials etc. (granted some of the combo trials will be run by the partnering company, but they still need to know what it takes to succeed. They will probably have to make the initial quantity of drugs for those trials too.)

I think that horse is still alive....

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