Replies to post #250326 on Innovation Pharmaceuticals Inc (IPIX)

[joseytheoutlawwales]

Nice post.

[Jhawker]

Thanks PP! This info is very important for this board to understand because as you piont out more than a few around here have lead people to believe that without BTD B-OM is dead in the water and will have 0 value!

[DaubersUP]

Excellent DD. Thanks

[Jhawker]

This should be stickyed!

[top123]

Very nice post PlentyP..Also just because a company that had BTD it does not mean it will get FDA drug approval. I am watching a company Biased Ligands drug ( TR*N ) they had BTD and just couple of weeks ago the company got rejested by the FDA for drug approval.

What TRUE long here like to see is for B-OM and other IPIX pipeline is to get FDA drug approval.

TIAB give it up the issue of BTD.

[scottsmith]

One key metric that chart is missing. How many of those companies were trading on the OTC?

[loanranger]

"Here is the interesting part. One might assume that BTD would results in FDA granting more Priority Reviews for drugs with BTD than for drugs with just FTD (BTD being so 'crucial'). Not so, as one can figure out from the above table. ALL approved drugs with FTD had also priority review, so did ALL approved drugs with BTD."


It would be more interesting if the goal was Priority Review, but obviously it's not. I'm looking forward to the Table...actually just stating the facts would be plenty...that tells us for a given recent period of time:
1. How many drugs that applied for FTD received the grant? How many of those were subsequently approved?
2. How many drugs that applied for BTD received the grant? How many of those were subsequently approved?

That would show that the grant to application ratio is a lot higher for FTD grantees, wouldn't it? (Of course it would, the standard is easier to meet.)

It would also show that the grant to approval ratio is a lot higher for BTD grantees, wouldn't it? (Of course it would, they met a higher standard in order to achieve the grant.)



"Priority Review is not automatic consequence of either FTD or BTD."
It's also not the ultimate goal. Approval is. And I think you'll find...in fact I suspect that you already know...that a BTD grant is far more statistically significant in terms of the likelihood of an approval than a FTD grant is.

"BTD? We don't need no stinkin' BTD!".
No, it's not needed, but the chances of approval are significantly better with it than they are without it. Right?


But maybe you have some numbers to prove me wrong?

[To infinity and beyond!]

you are to be congratulated on the effort it took to figure this out. The question is what it all means. i still think B OM can get approved but I am very nervous that NOT getting BTD is crucial.

After all B OM is so ideally positioned to get a BTD, no? You have a drug given in the simplest possible fashion to prevent a serious complication of cancer therapy when there is NO good alternative treatment. The setup wass perfect for B OM to get this designation.

Why the failure? That remains the question, and I continue to think it is a very important failure. When will we understand the reason? Was it connected to the term sheet failure? Or is it some technical problem, a minor issue? If so why no clarification from IPIX?

Sorry I still believe it is a big deal and wish we knew more.