Hi Spidey...
You do have valid points- like all of the data points and expected timelines being offered by PSTI in their own presentations, and the NIH supporting studies of PLX and incredible efficacy data.
All I know is that over the many years in pharmaceutical sales, pharma companies would send out launch dates for new medications, and sometimes, there would be a setback- such as "Additional data requested". I think it it has happened already to PSTI in patients with Pre-eclampsia Toxemia as one patient experienced a side effect possibly related to the product?? That kind of stuff has to be addressed no matter how sick the patient was.
Take any medication that is FDA approved and type in PI or Package Insert after the name of the medication on your browser. There you will find multiple sections such as Clinical Pharmacology (How the drug works and how the body reacts)/ Efficacy (with Trail Data)/ Dosing and Administration/ and of course my Bugaboo- Adverse Reactions (with trial data)... Here you will see that all medications are either studied in Healthy Individuals or patients with the Disease they are treating.
Allo suggests the PLX R18 has just been tweaked when compared to PLX Pad to fit the issues. I do not think the FDA is going approve a medication if it is in any way different than PLX.
For example pharma will try and extend a patent by adding a chemical ring to the existing approved drug that is going to loose it's patent. If they improve on efficacy or adverse events, or make the new agent once a day instead of three times a day, they must prove this with clinical studies. Look at omeprazole and esomeprazle- the second one is an isomer of the first, and it improved efficacy. But they still had to prove it with additional efficacy and adverse event studies.
But ARS may be different- urgency and compassionate use and the way the pipeline is set up through government may "Trump" the way the FDA works. This is the Great Unknown for us holders. I just struggle with large animal efficacy data with very little to show on side effects. It is definitely not how it works with the FDA- that's all I know!!
