Theralase Technologies Inc. V.TLT

The Pre-BTD effect.

[Maxcitrac]

If I understand correctly, the purpose of the Pre-BTD application is, if the FDA saw in the Pre-BTD application that there is a need for more data or more informations in order to satisfy the BTD application, the FDA through the Pre-BTD would tell TLT what is needed in order to present a BTD application that has all the necessary  informations and data needed for the full BTD approval.
In a way, we could say that the FDA through the Pre-BTD application is helping TLT to fill all the necessary informations needed to ensure that the BTD application will be approved.
If the Pre-BTD application is approved with the blessing of the FDA, then the BTD approval is almost 100% guaranteed.
What I am trying to say is, if the approval of the Pre-BTD mean that the BTD approval is almost 100% guaranteed, then the approval of the Pre-BTD with the blessing of the FDA could be interpreted like the full approval of the BTD by the investors sitting on the sideline, and these investors could start to buy into TLT, and the SP would increase accordingly.
It goes without saying that we need a news release saying that the Pre-BTD application has been approved by the FDA.

I am not sure my theory make sense but you never know.

[Legit62]

makes perfect sense, the question becomes whether they wait to announce BTD or whether next week or end of today they announce Pre BTD was okayed.

[StevenBirch]

I don't think they will put out a news release to say pre-BTD has been approved, just like before it would come in an update. Approval of pre-BTD is not material news and it's been over 3 weeks since it was submitted so my positive spin would be that it likely has been and we are waiting for BTD to be submitted/approved. They may put out an update as a way of informing us of pre-BTD, maybe

[Dreimer200]

Surely –if pre-BTD has been approved – that is a significant positive step – the removal of an element of doubt that has plagued the company – for what seems like years.    It would also be an indication that the management might – just possibly – be on the track of respecting the interests of shareholders – rather than viewing the company – understandably but annoyingly – as an

[chry200030]

I think you are right. But they would tell us if the pre-BTD is not approved. So, in this case, NO NEWS is GOOD NEWS.

[rollthedice10]

I pretty much agree. I see the Pre BTD as more of a screening process whereby if you make it through that, the FDA must be quite impressed and help you move to BTD. The FDA will want to cover their butts for sure, which is understandable. Frustrating for the applicants but I can see why FDA puts everyone through a rigorous process. It sure looks like TLT will make it through, but who knows how