Post by
TheGreenExpress on Nov 23, 2018 3:45pm
Does this make the success of PPP001 very low?
Found this article that i think relates to our PPP001. It's kinda got me on the fence as to the success of us actualy getting a DIN for a smokable drug. Let me know what you think.
FDA Commissioner Scott Gottlieb “Using a lung as a drug delivery vehicle isn’t optimal,” “That’s not to say that we wouldn’t evaluate it if it came in; it just wouldn’t be an optimal way to deliver an active ingredient,” https://www.bloomberg.com/news/articles/2018-05-07/don-t-expect-joints-if-the-fda-ever-approves-medical-marijuana
Comment by
LeafRider on Nov 23, 2018 4:51pm
This post has been removed in accordance with Community Policy
Comment by
moasat1 on Nov 23, 2018 5:25pm
Well said Leafrider. Stupid comment by the FDA and I love your example of asthma medicine. I think some nitrogen for angina is delivered that way as well.
Comment by
Sweeetydi on Nov 23, 2018 5:51pm
We already have orphan drug status for ppp001 granted by the FDA in the USA. This would lead to believe that with solid evidence, it will be granted FDA approval. Also, the patient population that TBP is studying is of key importance when considering the mode of ingestion.