Specifics from the FDA site re clinical holds and responses to
On January 8, AOLS submitted the response to the clinical hold. The FDA guideline is to respond in 30 days and it aims to do so in 90% of the cases. It has now been 53 business days. Has the company said what is going on? Do you know holeinyourpocket?
The quote is fine, but it does not state nor does the FDA state anywhere else that if you get orphan designation you get development support. You have an uncanny ability to find things on the web, interpret it incorrectly, and then post it as support for your opinion.
You are wrong. Orphan drug designation does not provide money for development. It does provide some tax incentives, but then those are only valuable if you have profits. It can also reduce some fees you have to pay to the FDA, but it provides zero funds for development. Just ask any of the 27 other companies that have received orphan designation for IPF.
I would guess that you are not a paid pumper, rather you are a "true believer" in this stock, and no facts will ever shake you from your delusions, or your losing stock position.
I see you have a hard time dealing with facts, particularly unwelcome ones. Nevertheless, an orphan designation is not a guarantee of funding or approval. Twenty-seven other companies already have an orphan designation for IPF. There's a lot of competition in this market and some very heavy hitters.
You state that this "will be wholly developed with government funding." Kindly point out the source of that government funding.
Here's a link to an FDA page showing all 28 compounds/companies that have received orphan drug designation for IPF:
I'm sure it will come eventually, but I want to check to make sure only 15% was withheld for the foreign dividend tax. In the past, my broker has screwed up, though Novartis IR was very helpful in getting it resolved.