$RLFTF (copy) Props to Alexandre below who linked
Post# of 653
1. They did have a CEO and other typical C-level suite guys as late as that report in 2016. Will have to do some digging to find out what happened there (if someone knows please let me know).
2. They mentioned even then their opinion is to outsource as much as they can and keep the company as "lean" as possible. They found using CRO's to do the research stuff saved money AND published research showed that CRO were on time 30% more often then doing research with in house folks. So I was wrong that how they are not ramping up and getting bigger in preparation of building off aviptadil is a sign something is amiss in the company. It seems that approach (right or wrong) is within their philosophy even back in 2016.
3. They did a phase II using aviptadil for sacroidosis and seemed to start a phase III. Tried googling the name of the phase III, but found nothing about what happened to it. Anybody know?
4. Their phase II for sarcoidosis was very interesting. It was done using an INHALED version which showed no adverse effects. So this most likely points to the INHL trial we have set up for COVID going off with no adverse effects. The study seemed not to make a difference in lung volumes in sarcoidosis based on how the results showed no change in TLC (total lung capacity) which are decreased in that disease state being a restrictive lung disease. No change in other lung parameters or gas exchange. They should have measured pulmonary pressures and right heart pressures as well to see if their was an pulmonary vasodilation and thus decrease in right sided heart strain, but oh well we can't get everything.
5. The phase II for sarcoidosis DID show once again SIGNIFICANT (75%+) decrease in inflammation via decreased TNF-alpha. This confirms nearly EVERY study to date via IV and now inhaled version it decreases inflammatory mediators. I have NO CLUE why their team didn't notice this and change direction to start trialing this for inflammatory conditions, i.e. sepsis, Inflammatory bowel disease, rheum. disease (RA, SLE, etc...).
As I have stated from the beginning this is BY FAR the most interesting aspect of this drug. It may be the "holy grail" of inflammation WITH no significant side effects via an easy route of administration (inhaled).
6. They made an agreement to offer to license aviptadil to a small, private biotech company for them to do the trials for INHL aviptadil for sarcoidosis and acute lung injury. The latter I am wondering if it went though will affect any revenue going forward for indications like that which is a precursor to ARDS by definition.
In that agreement they stated in 2018 it may also be for the RIGHTS to the patent for those indications if certain goals are met. I am assuming nothing materialized out of that agreement, but does anyone have an DD on that matter?
Maybe some of our European friends who have known the company and the biotech space in Europe will be able to flesh this part of the story out for us?
Either way that was a very interesting read on a company BEFORE they gained instant fame now due to COVID and their hopeful treatment.