This might be an unpopular post , but here goes:
Yeah, the FDA letter was harsh. Lets look back in time :
The company should know by now who it is dealing with - there has been enough of an indication. The company has 1 weapon - well designed trials. I have said this a few times - if we tried to hack our way to approval it will not work.
If we wanted 4 doses - we should have done a phase II on 4 does ? then used to get phase 3.
Our n values were always too low - the company left itself open. Not just once, but over and over again it has done this. You needed n > 1000 at least (n > 2000 probably). That would have allowed for stats that are hard to attack. An n of a what 100, means nothing.
Yes, it is sad what has happened, but I personally have been expecting it - the definition of insanity is to do the same thing over and over again and expect a different result. So I ask you - for long haulers - what's the n value ? Because if we rock up with an n of 10 , we have no hope.
In my profession we have a saying - if you don't have time to do it once, you really don't have time to do it twice or even 3 times.
Also , talking about the same thing over and over again and insanity - did you really expect our current leadership would not end up in this place ?
Going forward :
- Large N
- if you don't get the design you want, work out how to get it, even if its a phase we don't want to do
- only when you have the design you want (which is why they do phase II right) and what the letter is also saying - do the large n, and make it large enough to be hard to argue.
Looking back someone in this whole mess is probably a lot smarter than company management - they saw a company willing to skip the steps in hurry to cash , cut the n size etc. They gave it to them, knowing it would all be to their advantage later. Management should know by now - be smarter.
Yeah, the FDA letter was harsh. Lets look back in time :
The company should know by now who it is dealing with - there has been enough of an indication. The company has 1 weapon - well designed trials. I have said this a few times - if we tried to hack our way to approval it will not work.
If we wanted 4 doses - we should have done a phase II on 4 does ? then used to get phase 3.
Our n values were always too low - the company left itself open. Not just once, but over and over again it has done this. You needed n > 1000 at least (n > 2000 probably). That would have allowed for stats that are hard to attack. An n of a what 100, means nothing.
Yes, it is sad what has happened, but I personally have been expecting it - the definition of insanity is to do the same thing over and over again and expect a different result. So I ask you - for long haulers - what's the n value ? Because if we rock up with an n of 10 , we have no hope.
In my profession we have a saying - if you don't have time to do it once, you really don't have time to do it twice or even 3 times.
Also , talking about the same thing over and over again and insanity - did you really expect our current leadership would not end up in this place ?
Going forward :
- Large N
- if you don't get the design you want, work out how to get it, even if its a phase we don't want to do
- only when you have the design you want (which is why they do phase II right) and what the letter is also saying - do the large n, and make it large enough to be hard to argue.
Looking back someone in this whole mess is probably a lot smarter than company management - they saw a company willing to skip the steps in hurry to cash , cut the n size etc. They gave it to them, knowing it would all be to their advantage later. Management should know by now - be smarter.
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