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

To: stockdoc77 who wrote (50219)	2/8/2019 11:14:35 PM
From: ladyPI	Respond to of 63276

The FDA Is Basically Approving Everything. Here's The Data To Prove It. Thats the title to google. Forbes

To: stockdoc77 who wrote (50219)	2/8/2019 11:58:22 PM
From: kdd999	1 Recommendation Recommended By diaperdaddy Respond to of 63276

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....

To: stockdoc77 who wrote (50219)	2/9/2019 2:01:10 AM
From: allatwwk	Read Replies (1) \| Respond to of 63276

didn't doubt you stockdoc77; we've both been up here for ages. But since some were wondering where the data came from, its good to have it out there. Of all the things with getting turned down for AA, this is the one which makes me most uncomfortable/upset. Seems everyone else knows the formula ... though I'd ask this -- if IMMU does get approval on the second chance, will they switch columns for this analysis and make it 39 for 39?