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Mind on my Money

03/29/17 3:24 PM

#4387 RE: Seaheck #4385

Wish I got a tax "return"...haven't seen $$$ owed me in about a decade.
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Gem_trader29

03/29/17 4:39 PM

#4406 RE: Seaheck #4385

This looks like dollar stock not penny stock.. Soon enough imho.
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Stiggie

12/03/17 10:01 AM

#22599 RE: Seaheck #4385

Have been reading a lot this weekend about the processes that need to be taken to receive RMAT designation.

But can someone tell me which path of IND (investigational new drug) ENDV could be following?

There are three IND types:

An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.

Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR , Sec. 312.23 or Sec. 312.20. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.

Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

At this moment there are 15 approved products which received RMAT designation by the OTAT.

https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/default.htm

EDIT: was not my intention to reply on a post from several months ago...