Member Info for Nolupus

Even IF trial had reached statistical significance and even IF company intended to submit NDA to FDA would love to know how marketing approval and launch would by physically possible in 2018. Full results, Clinical Trial Report and completion of NDA would take several months even with rolling review. Then add 2 months for FDA to decide whether or not to accept NDA and another 6 months for fast track review. Utterly impossible. I have to agree with BASIC COMMON SENSE....

The rampers should be careful about spreading false rumeurs ...imo

You should VERIFY your sources before posting these hopeless propaganda papers...imo

Not a german company but a blogboard from a german association and written by a certain "jambon" which means ham in french..... Not a very reliable source imv......A plant/propaganda

@bermudashorts Well said, you are thinking straight :-)

If the scientific community is against you, how do you expect the FDA to give you approval ??

If the scientific community is against you, how do you expect the FDA to give you approval ??

Benlysta is on the market and even though the FDA would not consider it a very efficient drug, why would they consider giving approval to an even less effective drug even with no severe adverse side effects ?? They want to see Drugs that WORK...not just Safe but ineffective...imv

Highly Unlikely...imo If Lupuzor had beaten Benlysta, there would have been a chance but with these results...it's back to the drawing boards imv

Highly Unlikely...imo If Lupuzor had beaten Benlysta, there would have been a chance but with these results...it's back to the drawing boards imv

for their Press Release last week.... http://www.lupus.be/spip.php?rubrique54

Thank you, halfbutt....good to see an open mind on this BB

@CEO86 An imposter has arrived ...Nolupu5.....that's not me... I am trying to be objective and not negative....

@itsgambling I cannot see IMM going alone on a new P3 in lupus....The cost should be in the region of at least 50 million.. They have at this point a very hard choice to make...either find a partner to license Lupuzor or shelve it for the time being and use their resources for the rest of the pipeline...imo

@Pinwiz, Not directly but the CNRS commented on the very successful trial.....

Move over, Benlysta, we can beat up hands down .....heard that loads of times ...before the results came out ..... Ramp it UP.....

Does no harm so it benefits patients......Lupus patients,can thank you so much Tim.....

@Reflex, I never said that Lupuzor was going to fail...I just pointed out that IMM was being TOO confident.Lupus is a very complex disease and many companies have failed phase3.....and for that i got a hell of abuse.. The reality is that lot's of PI were taken in by the overly Optimistic Tim and saw themselves multi-millionnaires .... Safety is one thing but the drug has failed to beat even Benlysta, that is the reality and the rest can only be considered window dressing imo.... I always say, Hope for the best but be prepared for the worst... Best of luck to you...

It would also be interesting if IMM would clarify what they meant by "full remission" in the subgroup link: https://resources.lupus.org/entry/remission-basics

@4jams Do you really expect IMM to file with the FDA in the next couple of months ??