Dear Jackie,
This will be a difficult AGM for the company, you have a lot of unhappy shareholders and I
think you know you are the focus of their discontent. I have documented the following
questions for you and my advice to you is to answer them fully as I have suggested.
I have previously advised how professional “spin doctors” would manage some of the issues
the company has faced and there has been no reaction to that advice.
Question 1. Regarding SPL 7013 products:
a) Regarding the MHRA, what was the exact nature of their complaint and what has
Starpharma done to remediate the issue. You have stated you do not agree with
the MHRA position but that, I suggest, is irrelevant. What has been done to get
Viraleze back on pharmacy shelves in the U,K.
b) Regarding Europe, what marketing and advertising budget has been established
for Viraleze to support the web site and what are the target sales figures?
c) Regarding Europe and India what further arrangements are being pursued with
distribution partners and when do you anticipate these being active?
d) Why has the BV product been so disappointing?
e) What has Starpharma done to address sales and distribution issues with
licensees for the BV product?
f) On what date was application made to the TGA for approval of Viraleze?
g) Are there issues with TGA approval process that Starpharma need to address?
h) When do you anticipate receiving approval from the TGA for Viraleze?
i) Regarding viral conjunctivitis what licensing discussions have been undertaken?
j) Why do you not disclose sales performance for your retail products? Especially
when this information is published to pharmaceutical companies through the
pharmacy industry?
Question 2: Regarding DEP Docetaxel
a) How many licensing discussions have taken place to date?
b) Do you still expect to recover the development costs to date from the initial
licence fee?
c) Given the clinical trial participants were in advanced stages of their disease and
extensively pre-treated did DEP Docetaxel on its own deliver equal or better
efficacy to Taxotere.
d) In your opinion, would the Phase 2 results for DEP Docetaxel be sufficient to
apply for approval without a Phase 3 trial against Taxotere? This would, I
imagine, be based on improved safety.
e) Have you been able to assess the effectiveness of the DEP program on delivering
conjugates and what has this effect been?
f) What is you anticipated timing for a license agreement?
Question 3 Regarding DEP Cabazitaxel:
a) How many licensing discussions have taken place to date?
b) Do you still expect to recover the development costs to date from the initial
licence fee?
c) Given the clinical trial participants were in advanced stages of their disease and
extensively pre-treated did DEP Cabazitaxel on its own deliver equal or better
efficacy to Jevtana.
d) In your opinion, would the Phase 2 results for DEP Cabazitaxel be sufficient to
apply for approval without a Phase 3 trial against Jevtana? This would, I imagine,
be based on improved safety.
e) Have you been able to assess the effectiveness of the DEP program on delivering
conjugates and what has this effect been?
f) What is you anticipated timing for a license agreement?
Question 4 Regarding DEP Irinotecan:
a) How many licensing discussions have taken place to date?
b) Do you still expect to recover the development costs to date from the initial
licence fee?
c) Given the clinical trial participants were in advanced stages of their disease and
extensively pre-treated did DEP Irinotecan on its own deliver equal or better
efficacy to Camptosar?
d) In your opinion, would the Phase 2 results for DEP Irinotecan be sufficient to
apply for approval without a Phase 3 trial against Camptosar?
e) What is you anticipated timing for a license agreement?
Question 5 Regarding the NDA with the FDA:
a) Did Starpharma receive a Complete Response Letter (CRL) as described in the FDA
process?
b) What is the current status of the review process?
c) Has an action by Starpharma been identified by FDA as a precursor to further
review and what is that?
d) What are your plans to gain FDA approval for the BV treatment and when do you
think this will occur?
e) What is ITF Pharma doing to assist this process?
Question 6:
What is Starpharma doing to address poor communications to the investment community?
We feel like mushrooms!
Regards
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