I agree with almost everything you said except,
" You should never try to time the market". I sometimes try to time the market, particularly with industries that are highly cyclical.
It doesn't really apply here for me though.
I know what you mean about recommending stocks to other people who then seemingly panic sell at the worst times. This type of behaviour has made me really really hesitant to suggest any stocks to anyone, given they are unlikely to profit even on an ultimately successful stock suggestion given they have no stomach for volatility.
On another note, I just went over my notes on the eligibility criteria for TGA provisional approval. First two columns on the left spell out the criteria set out in the guidelines. The last column has my simple notes on how PAR will meet it.
Eligibility criteria for provisional determination| Column 1 | Column 2 | Column 3 | 1. Medicine
| a new indications medicine OR a new prescription medicine
| Yes. Indication.
|
2. Serious condition
| an indication of the medicine is the treatment, prevention or diagnosis of a life threatening or seriously debilitating condition
AND
| Yes - Severe OA can be a seriously debilitating condition.
|
3. Comparison against existing therapeutic goods
| either:
i.no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for provisionally registered goods)OR
ii.if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods
AND
| Yes to (i.) - There are no other therapeutic goods that are able to treat or prevent the condition. Opioids don't really treat the condition - they just mask the pain. The only other alternative is surgery for some patients but even that is not suitable for everyone.
|
4. Major therapeutic advance
| there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance
AND
| Yes. Phase 2b trial (n=112) met primary, secondary and exploratory endpoints - pain, function, BML and biomarker reduction. TGA SAS Scheme - 700+ patients have received PPS. As part of this, 88 patients have successfully completed clinical studies with 650 ongoing. EAP - 10 patients in the U.S have successfully completed treatment.
|
5. Clinical study plan
| the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years (starting on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine).
| Yes. Paradigm has had discussions with FDA, EMA (EU), and TGA to clarify the path to regulatory approval and inform the design of its Phase 3 clinical trials to ensure it meets with the agency’s advice and to concurrently generate clinical data. Currently expected to comprise of two studies - n=750 and confirmatory phase 3 n=400 to be run concurrently, in the U.S, Europe, Australia and possibly Japan.
|
I think there is a high probability they will succeed with their TGA approval after they successfully file their IND submission to the FDA for phase 3 trials as it seems firming up the phase 3 trials is what will be needed before TGA provisional approval is granted.
Once they start selling it under provisional approval, I think the company will attract significant interest, perhaps seeing a company lob a $5 billion+ offer for the company as a starting point.
My chief concerns aren't with the efficacy and safety of the drug - but of the IP and the relationship with bene pharmaChem, and I think it's this relationship which may be what is putting off some investors as well.
Given the potential upside however, I agree the risk - reward is very skewed and compelling.
All IMO only. I'm not an expert in clinical trials or the approvals processes, IP law etc. DYOR.
(20min delay)