< Im looking for something to differentiate it from CHTP but I dont see it yet. >
If you were smart enough, you would know that Vincristine Sulfate is a FDA approved drug, since 1963. The side effects of this formulation is well known and well documented. Marqibo on the other hand is the same Vincristine, encasulated in "fat bubble, liposomes. Patients will still benefit from its known therapeutic efficacy, without its known SAE's/side effects.
So TLON differentiates from CHTP because TLON's marqibo does not have any unknowns like CHTP's NOH drug (droxydopa).
I hear what you are saying and understand what you mean. However the FDA isnt going to approve it with flying colors. I bet it will get a CRL with FDA recommendations and put off for more information. They are goin to pour over trial results and new data.. not 1963. It is not a safe bet to say its approved.
Northera has been used in Japan for over 20 yrs, but the FDA still has concerns and wants more trials. Same will happen here Im afraid. Im being realistic as to the current trend of the FDA, the human factor, how many times has TLON brought this up for approval? If this is the first time, the percentages are not in favor for approval.
I'm assuming TLON is applying through the 505(b)(2) process, so they can actually use a lot of historical data as part of their NDA.
I'm not familiar with Northera, but I would say a previously approved FDA drug will have a lower barrier, even though the other drug was used for many years in Japan due to differences in regulatory requirements and in patient population (possibly different PK and metabolism).
Seattle genetics drug recently got approved with only 2 single agent phase II studies. Probably makes more sense to compare the data from those 2 briefing documents to get a better feel for approval.
< They are goin to pour over trial results and new data.. not 1963. It is not a safe bet to say its approved.>
I think TLON has been in communication with FDA, since ODAC. The positive 7-4-2 ODAC recommendation vote to approve, saw results an NEW data since 1963...think for a moment.
< Northera has been used in Japan for over 20 yrs >
This is not Japan, imo. So how many times has TLON brought up "Vincristine" for approval. Don't forget Vincristine is an approved drug here in the USA, unlike droxidopa, which is mostly experimental here in the USA.
You are a basher trying to play nice, or perhaps Adam. lol