Originally posted by Davisite
This is close enough to one question to answer clear.png
1. BIT needs to show that BIT225 has clinical benefit in patients. Not significant immunological changes, not results supportive of attacking HIV in an important reservoir, not a unique mode of action, but actual evidence that BIT225 helps make patients better or keep them healthy. BIT also needs to show that BIT225 does not have serious side effects when used for long periods of time (the old safe and effective).
The recent trial failed to show clinical benefit. It is possible what was observed will be a useful marker in a future trial designed to show clinical benefit, but this will require a new trial. This trial (which hasn't even been designed yet) will need to be another phase 2 trial because the regulators will not let you go to a large phase 3 trial without evidence of clinical benefit to patients in a phase 2 trial.
2. Yes if BIT had evidence of clinical benefit this would change my opinion of BIT as an investment. Having evidence of clinical benefit would mean discussions with large pharma companies might prove fruitful, but without this pharma companies are unlikely to be interested.
Outside of having evidence of clinical benefit BIT225 faces a few major hurdles.
a) The mode of action has not been used by other companies. Being first carries more risk.
b) It has been around for a long time so a lot of time has run out on the patent clock.
c) We don't have any evidence of how much of a problem resistance is with BIT225. Plenty of good HIV drugs have failed because resistance occurred at a high rate in the clinic.
d) The entire pharma industry is looking in a new direction regards HIV. There are trials now underway to try and achieve a cure. Unless BIT225 has clinical evidence that it will help in a cure, then they are unlikely to get pharma interest. No targeting HIV in macrophages is not evidence that it will be of use in a cure.
let everything sink be
Thanks for taking the time.
Apprecite your insights and will take some time to think them over rather give a flippant reply.
I do have a couple of follow on questions, more so for clarification and do ensure I am understanding you.
1. The “showing” of clinical benefit in trial patients
-When (in your opinion/expertise of course) is typical for disclosure? - Clearly the ASX rules play a factor, but hyperthectically, if BIT where to possess something truely bonefide in terms of “evidence of cure” and it was safe guarded by parents, would we already know?
2. When you say the trial failed to show clinical benefit.
-Is that your personal definition or categorically? I do trust your judgement/information however I ask because, well BIT are not behaving as it were a failure, and would likely spin it any other way until impossible to do so too. And in addition, in this particular trial (let alone generalising), I am unsure of what is typical.
3. In relation to what you mentioned about the protocols of progressing trial phases and the potential for requiring to repeat trials - What’s your take on on BIT’s posturing?
-If we take the focus away from the science and ambiguious language used in many BIT updates for he moment, and examine what is more comcrete/reliable
information on we have to work with (still keeping our doubts in mind of course)....
What do you make of...
A)Whether true or false, BIT have announced they are seeking/exploring commercialations partners.
B) MM bought in to whatever it is she is saddling.
C) The availability of any data that is caterogically negative (rather than just ambiguous) and or at least with certainty, dimishes BITs credibility. Is there any? / do you know of any? You point about the failed phase two trial stands out for me, but it hasn’t been portrayed like that to at all until our discussion. I appreciate that as something seriously worth looking into.
As I mentioned before I am novice investor. I do however back myself I’m strategy analysis in both human behavor and business behaviour.
My quick and well, instictive feelings is that BIT’s behaviour / postur8’gnwould be very questionable at best and I wouldn’t know, but even illegal and worst? (Please correct me if I’m wrong)should BIT not have something in their pockets worth the self determined and self perpetuating, self promotion.
Or,
By at least they’re own standards and moralities, they genuinely believe they have something. And they are essteinally risking everything on it. My only doubt is
the possibility that “significant immological effect” (whether true or false) is a Hail Mary to partner up, while the business is good health, and with potential and then carry on hiding any backwards/sidewards steps (clinicilly) in amongst the swell all other other changes that may occur due to a new partnership. This is bold notion and only a thought, though. I believe BIT to be genuinez
I’ll read thought all the other info you wrote and do my own researh.
Nutler
(20min delay)